| 1 |
NCT01859637 |
Terminated
Has Results |
Immunogenicity, Safety, and Efficacy of Zarzio®/Filgrastim HEXAL® in Patients With Severe Chronic Neutropenia |
- Severe Chronic Neutropenia
|
|
Interventional
|
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Anti- Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) Antibodies
- Number of Participants With Adverse Events (AEs)
- Change in Absolute Neutrophile Count (ANC)
|
6 |
All |
18 Years and older (Adult, Older Adult) |
NCT01859637 |
EP06-401 |
|
July 2011 |
March 2014 |
September 2015 |
May 22, 2013 |
March 28, 2016 |
March 28, 2016 |
- Medizinischen Hochschule (MHH) Hannover
Hannover, Germany - Karolinska Institut
Stockholm, Sweden
|
|
| 2 |
NCT01933971 |
Completed |
Evaluation of Dose-response, Pharmacodynamic and Pharmacokinetic Bioequivalence of Filgrastim in Healthy Male Volunteers After Single and Multiple-dose Subcutaneous Administration of the Test Injectable Formulation BK0023 vs. Neupogen® |
|
- Drug: Filgrastim test
- Drug: Filgrastim reference
|
Interventional
|
Phase 1 |
- Bio-ker S.r.l.
- Cross Research S.A.
- Nerviano Medical Sciences
- (and 2 more...)
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Area under the curve of absolute neutrophil count (AUCANCday1) and maximum absolute neutrophil count (ANCday1max); AUCANCday1-10 and AUCANCday1-8; ANCday1-10max and ANCday1-8max; AUCday1 and AUCss of filgrastim in serum.
- Area under the curve of CD34+ cell count (AUCCD34+) and maximum CD34+ cell count (CD34+max); maximum concentrations at steady state (Cssmax), Cmaxday1, time to achieve Cmax (Tmax), t1/2 and clearance of serum filgrastim
|
102 |
Male |
20 Years to 40 Years (Adult) |
NCT01933971 |
CRO-PK-06-175
2007DR1116 |
|
June 2007 |
April 2008 |
April 2008 |
September 4, 2013 |
September 9, 2013 |
|
- CROSS Research SA
Arzo, Ticino, Switzerland
|
|
| 3 |
NCT01713309 |
Completed |
Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With GCSF (Filgrastim) |
- Acute Respiratory Failure
- Critically Ill
|
|
Interventional
|
Phase 2
Phase 3 |
- Helsinki University Central Hospital
- The Swedish Research Council
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of adverse events
- follow up measures
|
59 |
All |
18 Years and older (Adult, Older Adult) |
NCT01713309 |
HBP01 |
HBP-Neupogen |
January 1996 |
June 1998 |
September 1998 |
October 24, 2012 |
October 29, 2012 |
|
- Helsinki University Central Hospital
Helsinki, Finland
|
|
| 4 |
NCT03029000 |
Terminated
Has Results |
Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants |
|
|
Interventional
|
Phase 3 |
- Teva Pharmaceutical Industries, Ltd.
- Teva Pharmaceutical Industries
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With at Least 2*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg) of Recipient Body Weight Collected in the First Apheresis on Day 5
- Percentage of Participants With at Least 2*10^6 CD34+ Cells/kg of Donor Baseline Body Weight Collected After the First Apheresis on Day 5
- Percentage of Participants With at Least 5*10^6 CD34+ Cells/kg of Recipient Body Weight Collected After the First Apheresis on Day 5
- (and 5 more...)
|
1 |
All |
18 Years to 60 Years (Adult) |
NCT03029000 |
TV44688-ONC-30054 |
GRANIX |
August 2, 2017 |
October 30, 2017 |
October 30, 2017 |
January 23, 2017 |
December 14, 2018 |
December 14, 2018 |
- Teva Investigational Site 14029
Duarte, California, United States - Teva Investigational Site 14025
La Jolla, California, United States - Teva Investigational Site 14023
Beech Grove, Indiana, United States - (and 6 more...)
|
|
| 5 |
NCT02783937 |
Unknown † |
Filgrastim for Premature Ovarian Insufficiency |
- Premature Ovarian Failure
|
- Biological: Filgrastim
- Drug: Saline
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Return of menses
- Pregnancy
- serum Estradiol
- (and 4 more...)
|
10 |
Female |
16 Years to 40 Years (Child, Adult) |
NCT02783937 |
OBGYN001 |
FIL-POI |
November 2016 |
December 2017 |
June 2018 |
May 26, 2016 |
November 29, 2016 |
|
|
|
| 6 |
NCT02923791 |
Completed |
A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product. |
|
- Biological: Filgrastim Hospira
- Biological: US-Approved Neupogen
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- The proportion of subjects with a negative baseline anti-drug antibody (ADA) test result and confirmed post-dose positive ADA test result at any time during the study.
- The proportion of subjects with a negative baseline ADA test result and post-dose positive neutralizing antibody result at any time during the study;
|
256 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02923791 |
C1121012
FILGRASTIM IMMUNOGENICITY US
COMPARATIVE IMMUNOGENICITY |
|
October 2016 |
January 2017 |
January 2017 |
October 5, 2016 |
February 23, 2017 |
|
- SeaView Research, Inc.
Coral Gables, Florida, United States - Seaview Jacksonville LLC
Jacksonville, Florida, United States - SeaView Research, Inc.
Miami, Florida, United States
|
|
| 7 |
NCT02766634 |
Completed |
A Research Study To Test How Multiple Doses Of Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given by Subcutaneous Injection (SC) (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen) |
- Neutropenia (Low White Blood Cell Count)
|
- Biological: Filgrastim Hospira (US)
- Biological: U.S.-approved Neupogen®
|
Interventional
|
Phase 1 |
- Pfizer
- Hospira, now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- The Area under the effect curve for CD34+ (AUECCD34+)
- Maximum observed value for CD34+ (CD34+max)
- Area under the serum filgrastim concentration versus time curve from time zero to 24 hours (AUC0-24)
- (and 5 more...)
|
60 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02766634 |
ZIN-FIL-1501
C1121003 |
|
March 2016 |
June 2016 |
June 2016 |
May 10, 2016 |
July 21, 2016 |
|
- SeaView Research, Inc.
Miami, Florida, United States - SeaView Research, Inc.
Miami, Florida, United States
|
|
| 8 |
NCT02078102 |
Recruiting |
A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma |
- Multiple Myeloma
- Non-Hodgkin's Lymphoma
|
- Drug: Meloxicam
- Drug: Filgrastim
|
Interventional
|
Phase 2 |
- Sherif S. Farag
- National Cancer Institute (NCI)
- Indiana University
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis
- Toxicity Profile of Meloxicam and Filgrastim
- Graft Composition of Peripheral Blood Stem Cell Collection
- Engraftment Kinetics of Meloxicam and Filgrastim
|
32 |
All |
18 Years and older (Adult, Older Adult) |
NCT02078102 |
IUCRO-0419
CA182947
1312925163 |
|
March 11, 2014 |
November 1, 2019 |
January 1, 2020 |
March 5, 2014 |
May 1, 2019 |
|
- Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
|
|
| 9 |
NCT02762799 |
Completed
Has Results |
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen® |
|
- Biological: Leucostim®
- Biological: Neupogen®
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- AUC (0-48 Hours)
- Cmax After Subcutaneous Injection
- Cmax After Intravenous Injection
- (and 14 more...)
|
60 |
Male |
18 Years to 45 Years (Adult) |
NCT02762799 |
BCD-002-1 |
|
July 18, 2016 |
November 11, 2016 |
November 11, 2016 |
May 5, 2016 |
December 18, 2018 |
December 18, 2018 |
|
|
| 10 |
NCT02766647 |
Completed |
A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen) |
- Neutropenia (Low White Blood Cell Count)
|
- Biological: Filgrastim Hospira (US)
- Biological: US-approved Neupogen®
|
Interventional
|
Phase 1 |
- Pfizer
- Hospira, now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Area under the serum filgrastim concentration versus time curve from zero to infinity (AUC0-∞)
- Maximum serum filgrastim concentration (Cmax)
- Area under the effect curve for Absolute Neutrophil Count (ANC) (AUEC ANC)
- (and 7 more...)
|
24 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02766647 |
ZIN-FIL-1502
C1121002 |
|
December 2015 |
February 2016 |
March 2016 |
May 10, 2016 |
May 10, 2016 |
|
- SeaView Research, Inc
Miami, Florida, United States
|
|
| 11 |
NCT02190721 |
Completed
Has Results |
A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement |
|
|
Interventional
|
Phase 2 |
- Teva Pharmaceutical Industries, Ltd.
- Teva Pharmaceutical Industries
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Participants With Adverse Events (AEs)
- Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results
- Participants With Potentially Clinically Significant Abnormal Hematology Results
- (and 30 more...)
|
50 |
All |
1 Month to 16 Years (Child) |
NCT02190721 |
XM02-ONC-201
2014-001772-55 |
|
May 12, 2015 |
April 4, 2017 |
April 4, 2017 |
July 15, 2014 |
July 31, 2018 |
July 31, 2018 |
- Teva Investigational Site 12958
Long Beach, California, United States - Teva Investigational Site 12951
Los Angeles, California, United States - Teva Investigational Site 12954
Jackson, Mississippi, United States - (and 30 more...)
|
|
| 12 |
NCT03486080 |
Enrolling by invitation |
Study of Dutogliptin in Combination With Filgrastim in Post-Myocardial Infarction |
- Acute Myocardial Infarction
- Acute Myocardial Ischemia
- STEMI - ST Elevation Myocardial Infarction
|
- Drug: Dutogliptin Tartrate
- Drug: Filgrastim Injectable Product
- Drug: Placebos
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Safety assessment of the number of Grade 3 and 4 treatment emergent AEs or serious AEs (SAEs) as assessed by CTCAE v4.0.AEs (SAEs) as assessed by CTCAE v4.0.
- Cardiovascular efficacy LVEF
- Cardiovascular efficacy LVESV
- (and 6 more...)
|
140 |
All |
18 Years to 85 Years (Adult, Older Adult) |
NCT03486080 |
REC-DUT-002 |
|
December 7, 2018 |
December 2019 |
March 2020 |
April 3, 2018 |
May 20, 2019 |
|
- Cedars-Sinai Medical Center, Heart Institute
Los Angeles, California, United States - Scripps Clinical Medical Group
San Diego, California, United States - Stanford University
Stanford, California, United States - (and 20 more...)
|
|
| 13 |
NCT01519700 |
Completed
Has Results |
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim |
- Chemotherapy Associated Neutropenia
- Breast Cancer
|
- Drug: EP2006
- Drug: Filgrastim
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy
- Incidence of Febrile Neutropenia
- Number of Days of Fever
- (and 4 more...)
|
218 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01519700 |
EP06-302
2010-024481-22 |
PIONEER |
December 2011 |
June 2013 |
June 2013 |
January 27, 2012 |
May 6, 2015 |
April 7, 2015 |
- Insitut Onkologie a Rehabilitaca na Plesi
Ves pod Plesi 110, Czech Republic - Semmelweis Egyetem, III. Belgyogyaszati Klinika
Budapest, Hungary - Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia
Budapest, Hungary - (and 23 more...)
|
|
| 14 |
NCT00785525 |
Recruiting |
Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors |
|
|
Interventional
|
Phase 3 |
- Center for International Blood and Marrow Transplant Research
- National Marrow Donor Program
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from NMDP donors.
- Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis
- Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients
- Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors
|
40000 |
All |
18 Years to 60 Years (Adult) |
NCT00785525 |
PBSC |
|
February 1997 |
January 2022 |
January 2022 |
November 5, 2008 |
June 14, 2017 |
|
- City of Hope National Medical Center
Duarte, California, United States - NMDP at Northern California & Northwest District
Oakland, California, United States - Blood Bank of San Bernardino & Riverside Cts.
San Bernardino, California, United States - (and 52 more...)
|
|
| 15 |
NCT02816164 |
Active, not recruiting |
A Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Febrile Neutropenia |
- Early Stage Breast Cancer
|
|
Interventional
|
Phase 4 |
- Ottawa Hospital Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Febrile neutropenia
- Treatment-related hospitalization
- Chemotherapy dose delay
- (and 2 more...)
|
176 |
All |
19 Years and older (Adult, Older Adult) |
NCT02816164 |
OTT 16-04 |
REaCT-G2 |
September 2016 |
December 2019 |
December 2020 |
June 28, 2016 |
March 4, 2019 |
|
- The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
|
|
| 16 |
NCT01987596 |
Unknown † |
Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer |
- Childhood Choroid Plexus Tumor
- Childhood Medulloblastoma
- Childhood Pineoblastoma
- (and 8 more...)
|
|
Interventional
|
Phase 3 |
- Barbara Ann Karmanos Cancer Institute
- National Cancer Institute (NCI)
- Children's Hospital of Michigan
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Days to ANC greater than or equal to 1,000/uL from the start of chemotherapy
- Incidence of febrile neutropenia
- Incidence of hospitalization
- (and 6 more...)
|
23 |
All |
1 Year to 25 Years (Child, Adult) |
NCT01987596 |
2013-062
NCI-2013-02001
P30CA022453 |
|
August 2013 |
September 30, 2017 |
September 30, 2017 |
November 19, 2013 |
March 30, 2017 |
|
- Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
|
|
| 17 |
NCT01285219 |
Completed |
A Study Comparing Pegylated Filgrastim and Filgrastim in Support for Chemotherapy |
|
- Drug: pegylated filgrastim and filgrastim
- Drug: filgrastim and pegylated filgrastim
|
Interventional
|
Phase 3 |
- Chinese Academy of Medical Sciences
- Fujian Cancer Hospital
- Beijing Chest Hospital
- (and 12 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Protective rate of grade 4 neutropenia
- rate of grade 3/4 neutropenia
- time to neutrophil recovery
- (and 6 more...)
|
337 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01285219 |
PEG3
2002SL0047 |
|
January 2006 |
May 2007 |
December 2008 |
January 27, 2011 |
January 27, 2011 |
|
|
|
| 18 |
NCT01238562 |
Completed |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients |
|
|
Interventional
|
Phase 1 |
- Xiamen Amoytop Biotech Co., Ltd.
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
- Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study.
- Measurement of serum concentration of drugs for Pharmacokinetic study.
|
30 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01238562 |
TB1004CSF |
Filgrastim |
April 2010 |
November 2011 |
November 2011 |
November 10, 2010 |
February 4, 2013 |
|
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
|
|
| 19 |
NCT00115128 |
Completed |
Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Spleen fold change measured by ultrasound
- Spleen change associations with filgrastim dose and hematologic variables
|
309 |
All |
18 Years and older (Adult, Older Adult) |
NCT00115128 |
20020143 |
|
November 2003 |
May 2007 |
September 2007 |
June 22, 2005 |
May 13, 2013 |
|
|
|
| 20 |
NCT01541072 |
Terminated |
Lymphocyte Reconstitution After Administration of Pegfilgrastim Versus Filgrastim After Peripheral Stem Cell Transplantation |
|
- Drug: Pegfilgrastim
- Drug: Filgrastim
|
Interventional
|
Not Applicable |
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 3 months kinetics of lymphocyte reconstitution, in the two arms
- 6 months kinetics of lymphocyte reconstitution, in the two arms
- 6 months kinetics of lymphocyte subsets reconstitution by phenotyping, in the 2 arms
- (and 8 more...)
|
34 |
All |
18 Years and older (Adult, Older Adult) |
NCT01541072 |
ET2011-010
2011-A00662-39 |
PALM2 |
February 2012 |
June 2014 |
September 2014 |
February 29, 2012 |
November 1, 2016 |
|
- CHU Clermont-Ferrand, Hôpital d'Estaing
Clermont-Ferrand, France - Centre Leon Berard
Lyon, France
|
|
| 21 |
NCT01617577 |
Completed
Has Results |
Efficacy and Safety of Filgrastim in Alzheimer's Disease |
|
- Drug: G-CSF; filgrastim
- Drug: Placebo
|
Interventional
|
Phase 1
Phase 2 |
- University of South Florida
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
|
8 |
All |
55 Years and older (Adult, Older Adult) |
NCT01617577 |
ADDF-GCSF |
FFAD |
June 2009 |
February 2012 |
February 2012 |
June 12, 2012 |
December 27, 2012 |
December 27, 2012 |
- USF/Byrd Alzheimer's Center
Tampa, Florida, United States
|
|
| 22 |
NCT02814110 |
Recruiting |
Efficacy Safety of Granulocyte Colony-stimulating Factor Treatment Children and Adolescents With Muscular Dystrophy |
- Increase of Muscle Strength in Patients With Muscular Dystrophy
|
- Drug: Granulocyte colony-stimulating factor (Filgrastim)
|
Interventional
|
Phase 1 |
- Medical University of Bialystok
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Increase in muscle strength in patients with muscular dystrophy
|
27 |
All |
5 Years to 15 Years (Child) |
NCT02814110 |
UMB 143-20899 P |
|
March 1, 2013 |
December 31, 2017 |
December 31, 2018 |
June 27, 2016 |
September 14, 2017 |
|
- Department of Pediatric Rehabilitation
Białystok, Podlaskie, Poland
|
|
| 23 |
NCT02225652 |
Completed |
A Phase II Study of Dose Density Regimen With Fluorouracil, Epirubicin and Cyclophosphamide at Days 1, 4 Every 14 Days With Filgrastim Support Followed by Weekly Paclitaxel in Women With Primary Breast Cancer. |
- Women With Primary Breast Cancer
|
- Drug: FEC (Fluorouracil, Epirubicin, Cyclophosphamide) + filgrastim + paclitaxel
|
Interventional
|
Phase 2 |
- Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Tolerability of the treatment
- Toxicity
- Progression-free survival (PFS)
- (and 3 more...)
|
11 |
Female |
18 Years to 70 Years (Adult, Older Adult) |
NCT02225652 |
IRST174.05
2010-020772-38 |
|
September 2010 |
September 2013 |
July 2014 |
August 26, 2014 |
August 26, 2014 |
|
- Irccs Irst
Meldola, FC, Italy
|
|
| 24 |
NCT01222819 |
Terminated |
SubCutaneous (SC) Versus Intravenous (IV) Granulocyte Colony Stimulating Factors (G-CSF) for the Treatment of Neutropenia in Hospitalized Haemato-oncological Patients |
|
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary efficacy outcome
- Primary safety outcome
- Will include rates of infection, fever days, hospital stay.
- Will include patient's satisfaction, other clinical endpoints and adverse events
|
120 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT01222819 |
5981 |
G-CSF |
January 2011 |
December 2012 |
April 2013 |
October 18, 2010 |
April 6, 2016 |
|
- Rabin Medical Center; Beilinson Hospital and Davidoff Cancer Center
Petah Tikva, Israel
|
|
| 25 |
NCT01766934 |
Active, not recruiting |
Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors |
- Hematopoietic Stem Cell Mobilization
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim.
- Efficacy assessment in terms of the CD34+ cell count.
|
245 |
All |
18 Years and older (Adult, Older Adult) |
NCT01766934 |
EP06-501 |
SMART |
May 2011 |
August 2024 |
August 2024 |
January 11, 2013 |
December 13, 2018 |
|
- German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Transfusion medicine und Immunohematology Frankfurt am Main
Frankfurt/Main, Hessen, Germany - German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Clinical Transfusion medicine and Immunogenetics Ulm (IKT)
Ulm, Germany
|
|
| 26 |
NCT02806791 |
Unknown † |
Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment |
|
|
Observational
|
|
- Azienda Ospedaliera San Giovanni Battista
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Collection of autologous stem cells (time the median of achieving> 20 CD34 + / ul circulating)
- Trend in blood counts after discharge values
- Collection of autologous stem cells (total hematopoietic stem cells CD34 + * 10 ^ 6 / kg collected)
- (and 12 more...)
|
300 |
All |
Child, Adult, Older Adult |
NCT02806791 |
BIO-AUTO 06-15 |
|
May 2016 |
May 2016 |
|
June 21, 2016 |
June 21, 2016 |
|
- Aou Citta' Della Salute E Della Scienza Di Torino, Divisione Di Ematologia, Sscvd Trapianto Allogenico
Torino, Italy
|
|
| 27 |
NCT03549728 |
Not yet recruiting |
Effect of Granulocyte Colony-stimulating Factor on Clinical Pregnancy Rate in Patients With Endometriosis |
- Recurrent Implantation Failure
- Endometriosis
|
- Drug: Granulocyte Colony-Stimulating Factor
- Procedure: Intrauterine infusion of normal saline
|
Interventional
|
Phase 2 |
- Amira Magdi Guergues Selim
- Ain Shams Maternity Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Supportive Care
|
- Clinical pregnancy rate
- Chemical pregnancy rate
- Implantation rate
- (and 2 more...)
|
88 |
Female |
20 Years to 40 Years (Adult) |
NCT03549728 |
2808 |
|
June 2018 |
October 2018 |
December 2018 |
June 8, 2018 |
June 8, 2018 |
|
|
|
| 28 |
NCT01079676 |
Completed |
A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer |
- Neutropenia in Breast Cancer
|
- Drug: Filgrastim (Eurofarma)
- Drug: Filgrastim (Granulokine, Amgen)
|
Interventional
|
Phase 3 |
- Eurofarma Laboratorios S.A.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy, according to the classification Common Terminology Criteria for Adverse Events (CTC-AE)
- The febrile neutropenia rate.
|
220 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01079676 |
EF-026 |
|
March 2011 |
April 2011 |
October 2012 |
March 3, 2010 |
October 16, 2012 |
|
- Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil - Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil - CEPHO - Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil - (and 3 more...)
|
|
| 29 |
NCT03317899 |
Recruiting |
Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma |
- Non-Hodgkin's Lymphoma
- Multiple Myeloma
|
- Procedure: Hematopoietic Cell Transplantation
- Drug: Tbo-filgrastim
|
Interventional
|
Phase 2 |
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- Thomas Jefferson University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of days to discharge
- Median days post autologous hematopoietic cell transplantation (auto HSCT) to neutrophil engraftment
- Median days post auto HSCT to platelet engraftment
- (and 7 more...)
|
140 |
All |
18 Years and older (Adult, Older Adult) |
NCT03317899 |
17D.404 |
|
October 12, 2017 |
June 2021 |
June 2022 |
October 23, 2017 |
May 24, 2018 |
|
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
|
|
| 30 |
NCT02098109 |
Completed
Has Results |
Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma |
- Multiple Myeloma
- Lymphoma, Non-Hodgkin
|
- Drug: XM02 Filgrastim
- Drug: Filgrastim
- Procedure: Apheresis
- (and 2 more...)
|
Interventional
|
Phase 2 |
- Washington University School of Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
- Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
- Comparison of the Time to Neutrophil Engraftment Between the Two Arms
- (and 6 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT02098109 |
201403068 |
|
August 20, 2014 |
June 10, 2016 |
September 18, 2016 |
March 27, 2014 |
July 18, 2017 |
July 18, 2017 |
- Washington University School of Medicine
Saint Louis, Missouri, United States
|
|
| 31 |
NCT00114764 |
Completed |
Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML) |
|
- Drug: filgrastim
- Drug: pegfilgrastim
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.
- Duration of severe neutropenia during induction chemotherapy
|
84 |
All |
18 Years and older (Adult, Older Adult) |
NCT00114764 |
20020163 |
|
March 2003 |
April 2004 |
August 2004 |
June 20, 2005 |
October 31, 2008 |
|
|
|
| 32 |
NCT00050674 |
Completed |
Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma |
- Non-small Cell Lung Cancer
|
|
Interventional
|
Phase 2 |
- Schwartzberg, Lee, M.D.
- Amgen
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT00050674 |
SD01-20010120 |
|
November 2001 |
February 2007 |
February 2007 |
December 18, 2002 |
December 27, 2012 |
|
- The West Clinic, PC
Southaven, Mississippi, United States - The West Clinic, PC
Memphis, Tennessee, United States
|
|
| 33 |
NCT01899326 |
Unknown † |
Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant |
- DS Stage I Plasma Cell Myeloma
- DS Stage II Plasma Cell Myeloma
- DS Stage III Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
|
- Drug: Desipramine Hydrochloride
- Biological: Filgrastim
- Other: Laboratory Biomarker Analysis
|
Interventional
|
Not Applicable |
- Albert Einstein College of Medicine
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Success rate of stem cell mobilization (SCM) using filgrastim and desipramine to collect > 5 x 10^6 cluster of differentiation (CD)34/kg in patients with multiple myeloma (MM) who are first time mobilizers or unexposed to alkylating agents
- Success rate of SCM using filgrastim and desipramine to achieve a total collection of > 5 x 10^6 CD34/kg in patients with MM who failed prior mobilization or were exposed to alkylator therapy or are predicted to be difficult to mobilize
- Average number of days of apheresis required to collect > 5 x 10^6 CD34+/kg
- (and 3 more...)
|
9 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01899326 |
2012-230
NCI-2013-01212
11-010
P30CA013330 |
|
December 2012 |
March 2015 |
|
July 15, 2013 |
January 12, 2016 |
|
- Albert Einstein College of Medicine
Bronx, New York, United States
|
|
| 34 |
NCT01543971 |
Completed |
Safety and Efficacy of TXA127 and Neupogen to Increase Peripheral Blood Stem Cells (PBSCs) |
- Miscellaneous Peripheral Blood Cell Abnormalities
|
- Drug: TXA127
- Drug: Neupogen (filgrastim)
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of participants with adverse events as a measure of safety and tolerability
- Preliminary effectiveness as assessed by changes in the concentration of peripheral blood stem cells (CD34+) and other hematologic parameters.
|
18 |
All |
18 Years to 45 Years (Adult) |
NCT01543971 |
TXA127-2009-003 |
|
December 2009 |
December 2009 |
March 2010 |
March 5, 2012 |
August 31, 2016 |
|
- Charles River Clinical Servies Norhtwest
Tacoma, Washington, United States
|
|
| 35 |
NCT01076270 |
Terminated
Has Results |
Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies |
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Acute Myeloid Leukemia in Remission
- (and 80 more...)
|
- Drug: plerixafor
- Biological: filgrastim
- Procedure: peripheral blood stem cell transplantation
- Procedure: allogeneic hematopoietic stem cell transplantation
|
Interventional
|
Not Applicable |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Successful Collection of Stem Cells
- CD34-positive Cells Collected
|
1 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01076270 |
2385.00
NCI-2010-00252 |
|
June 2010 |
January 2011 |
February 2011 |
February 26, 2010 |
June 28, 2017 |
March 31, 2017 |
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
|
|
| 36 |
NCT00410696 |
Completed |
Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy |
- Hematological Neoplasms
- Tumors
|
- Drug: Filgrastim
- Drug: Pegfilgrastim
|
Interventional
|
Phase 2 |
- Armando Santoro, MD
- Istituto Clinico Humanitas
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Duration of aplasia period
- Immunological reconstitution
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT00410696 |
ONC-2006-001
EUDRACT 2006-001409-27 |
|
September 2006 |
November 2008 |
November 2008 |
December 13, 2006 |
July 1, 2013 |
|
- Istituto Clinico Humanitas
Rozzano, Milan, Italy
|
|
| 37 |
NCT02037256 |
Unknown † |
Bortezomib and Filgrastim in Promoting Stem Cell Mobilization in Patients With Non-Hodgkin Lymphoma or Multiple Myeloma Undergoing Stem Cell Transplant |
- Adult Grade III Lymphomatoid Granulomatosis
- B-cell Chronic Lymphocytic Leukemia
- Contiguous Stage II Adult Burkitt Lymphoma
- (and 86 more...)
|
- Drug: bortezomib
- Biological: filgrastim
- Procedure: autologous hematopoietic stem cell transplantation
|
Interventional
|
Not Applicable |
- Barbara Ann Karmanos Cancer Institute
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Increase in levels of circulating PBSC by at least two-fold in the blood and in the apheresis collections in a 4-day collection protocol
- Neutrophil engraftment
- Co-mobilization of lymphoma or myeloma cells by bortezomib and filgrastim
- Mobilization of dendritic cell subsets pDCI and pDC2 and the ratio DC1/DC2
|
20 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02037256 |
2008-134
NCI-2012-01173
P30CA022453 |
|
July 2011 |
June 2017 |
June 2017 |
January 15, 2014 |
May 24, 2017 |
|
- Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
|
|
| 38 |
NCT02521441 |
Completed |
A Phase II, Dose-finding Study of F-627 in Patients With Breast Cancer Receiving Myelotoxic Chemotherapy. |
|
- Biological: F-627
- Biological: Filgrastim
|
Interventional
|
Phase 2 |
- Generon (Shanghai) Corporation Ltd.
- Fudan University
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- (and 10 more...)
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The duration of moderate or severe (grade 3 and 4, respectively) neutropenia
- The incidence rates of Grade 3 and Grade 4 neutropenia
- The duration in days of Grade 3 and Grade 4 neutropenia for cycle 2 to 4.
- (and 3 more...)
|
138 |
Female |
18 Years to 70 Years (Adult, Older Adult) |
NCT02521441 |
SP-CDR-1-1302 |
|
July 3, 2014 |
September 20, 2015 |
December 22, 2015 |
August 13, 2015 |
February 23, 2018 |
|
- Fudan University Shanghai Cancer Center
Shanghai, China
|
|
| 39 |
NCT01719432 |
Recruiting |
Effect of Body Mass on Filgrastim Pharmacokinetics |
- Hematological Malignancy
- Neutropenia
|
|
Observational
|
|
- Aaron Cumpston, PharmD, BCOP
- West Virginia University
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Systemic clearance of filgrastim in obese and non-obese patients
- Alpha and beta half-life of filgrastim in obese and non-obese patients
- Maximum concentration (Cmax) of filgrastim in obese and non-obese patients
- (and 2 more...)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT01719432 |
WVU 021112 |
|
December 5, 2012 |
December 2018 |
December 2018 |
November 1, 2012 |
May 30, 2018 |
|
- West Virginia University Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States
|
|
| 40 |
NCT03323541 |
Completed |
Use of Zarzio® in Post-autologous Stem Cell Transplantation Procedure |
- Multiple Myeloma
- Non-hodgkin Lymphoma
- Hodgkin Lymphoma
|
- Drug: Filgrastim Prefilled Syringe [Zarzio®]
|
Observational
|
|
- University Hospital, Brest
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- time to bone marrow recovery
|
62 |
All |
18 Years and older (Adult, Older Adult) |
NCT03323541 |
ZAPA |
ZAPA |
November 3, 2016 |
December 31, 2016 |
December 31, 2016 |
October 27, 2017 |
September 21, 2018 |
|
|
|
| 41 |
NCT02685111 |
Recruiting |
Intermittent G-CSF in Patients With Breast Cancer Receiving Adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) |
- Breast Cancer
- Neutropenia
- Febrile Neutropenia
|
- Drug: Filgrastim
- Drug: Peg-filgrastim
|
Interventional
|
Phase 2 |
- Asan Medical Center
- Kyowa Hakko Kirin Co., Ltd
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Cumulative incidence of febrile neutropenia
- Incidence of febrile neutropenia at each cycle
- Rates of anti-microbial use
- (and 4 more...)
|
162 |
Female |
19 Years to 70 Years (Adult, Older Adult) |
NCT02685111 |
AMC 2015-1143 |
|
February 2016 |
December 2018 |
March 2019 |
February 18, 2016 |
August 29, 2017 |
|
- Asan Medical Center
Seoul, Korea, Republic of
|
|
| 42 |
NCT00207792 |
Unknown † |
Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation |
|
|
Interventional
|
Phase 3 |
- Centre National de Greffe de Moelle Osseuse
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
160 |
All |
16 Years to 45 Years (Child, Adult) |
NCT00207792 |
GCSF |
|
July 2005 |
|
|
September 21, 2005 |
November 6, 2007 |
|
- Centre National de Greffe de Moelle Osseuse
Tunis, Tunisia
|
|
| 43 |
NCT00932217 |
Unknown † |
Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma |
- G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim
|
- Drug: filgrastim
- Drug: lenograstim
|
Interventional
|
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- febrile episode
- Documented infectious episodes Collection efficiency (CD34+ cells/kilo) Mobilization days Safety
|
180 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00932217 |
Pisa 01 |
|
December 2004 |
April 2007 |
|
July 3, 2009 |
July 3, 2009 |
|
|
|
| 44 |
NCT00038558 |
Completed |
Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy |
|
- Drug: Filgrastim SD/01
- Drug: Adriamycin
- Drug: Bleomycin
- (and 2 more...)
|
Interventional
|
Phase 3 |
- M.D. Anderson Cancer Center
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy
|
25 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT00038558 |
ID01-087 |
|
November 2001 |
February 2004 |
March 2005 |
June 3, 2002 |
October 31, 2018 |
|
- UT MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 45 |
NCT03023774 |
Completed |
Use of Gcsf in Patients With Recurrent Ivf/Icsi Failure |
|
|
Interventional
|
Not Applicable |
- Ain Shams Maternity Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- increase in endometrial thickness (above 7 mm)
- chemical pregnancy (serum beta hCG titre more than (25 mili liter international unit (mIU)/ml) and clinical pregnancy defined as the presence of an intrauterine gestational sac on transvaginal ultrasound (TVS)as 6 weeks.
|
20 |
Female |
up to 36 Years (Child, Adult) |
NCT03023774 |
ABT-1233-RV |
|
June 2016 |
October 2016 |
December 2016 |
January 18, 2017 |
January 18, 2017 |
|
|
|
| 46 |
NCT01315470 |
Unknown † |
Use of Granulocyte Colony-stimulating Factor for the Treatment of Recurrent Implantation Failure in IVF Patients |
|
- Drug: neupogen administration for women with recurrent IVF failure
|
Interventional
|
Phase 1 |
- Hadassah Medical Organization
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- pregnancy rate
- endometrial thickness during IVF treatment
- endometrial thickness
|
20 |
Female |
20 Years to 45 Years (Adult) |
NCT01315470 |
GCSF-HMO-CTIL |
|
June 2011 |
January 2013 |
March 2013 |
March 15, 2011 |
March 24, 2011 |
|
- Hadassah Ein Karem
Jerusalem, Israel - Hadassah Ein Karem
Jerusalem, Israel
|
|
| 47 |
NCT02184897 |
Unknown † |
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization |
|
- Drug: lenograstim 10 microgram/kg/day
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- pharmacokinetic data of lenograstim
- pharmacodynamic data: CD34+ cell count by flow cytometry
- pharmacodynamic data: absolute neutrophil count
- pharmacodynamic data: hematopoietic progenitor cells (HPC)
|
24 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02184897 |
AMC_MM01 |
|
July 2014 |
August 2016 |
December 2016 |
July 9, 2014 |
July 26, 2016 |
|
- Asan Medical Center, University of Ulsan College of Medicine
Seoul, Korea, Republic of - Asan Medical Center
Seoul, Korea, Republic of
|
|
| 48 |
NCT01818284 |
Completed
Has Results |
Plerixafor for Stem Cell Mobilization in Normal Donors |
- Blood And Marrow Transplantation
|
- Drug: Filgrastim
- Drug: Plerixafor
- Procedure: Apheresis Procedure
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- Proteonomix, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC)
- Feasibility in Mobilizing PBPC in Donors: Number of Donors Reaching Stem Cell Target Collection on First Day of Collection Following Treatment of Filgrastim Plus Plerixafor
|
22 |
All |
10 Years and older (Child, Adult, Older Adult) |
NCT01818284 |
2012-0579
NCI-2013-02209 |
|
October 2013 |
June 2016 |
June 2016 |
March 26, 2013 |
April 23, 2019 |
April 23, 2019 |
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 49 |
NCT01946152 |
Active, not recruiting |
Pomalidomide, Dexamethasone, and Filgrastim-sndz in Treating Patients With Relapsed or Refractory Multiple Myeloma |
- Multiple Myeloma-Light Chain Only
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
|
- Drug: Dexamethasone
- Biological: Filgrastim-sndz
- Other: Laboratory Biomarker Analysis
- Drug: Pomalidomide
|
Interventional
|
Phase 1
Phase 2 |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose-limiting toxicity (Phase I)
- Recommended phase II dose of pomalidomide and dexamethasone, when both agents are administered together with granulocyte-colony stimulating factor (filgrastim) (Phase I)
- Best overall response defined using the International Myeloma Working Group Uniform Response Criteria with the addition of minor response according to the European Group for Blood and Marrow Transplant criteria (IMWG-URC)
- (and 5 more...)
|
55 |
All |
18 Years and older (Adult, Older Adult) |
NCT01946152 |
2013-0018
NCI-2014-01270
NCI-2014-00159
P30CA016672 |
|
March 5, 2014 |
March 1, 2021 |
March 1, 2021 |
September 19, 2013 |
May 16, 2019 |
|
- M D Anderson Cancer Center
Houston, Texas, United States
|
|
| 50 |
NCT01266447 |
Completed
Has Results |
Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer |
- Cervical Adenocarcinoma
- Cervical Adenosquamous Carcinoma
- Cervical Small Cell Carcinoma
- (and 5 more...)
|
- Biological: Filgrastim
- Other: Laboratory Biomarker Analysis
- Biological: Pegfilgrastim
- (and 2 more...)
|
Interventional
|
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Tumor Response
- Number of Patients With Dose-limiting Toxicities (in Safety lead-in)
- Adverse Events (Grade 3 or Higher) During Treatment Period
- (and 3 more...)
|
27 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01266447 |
NCI-2011-02659
GOG-0127W
CDR0000691281
U10CA180868
U10CA027469 |
|
February 2011 |
January 2016 |
January 2016 |
December 24, 2010 |
July 12, 2017 |
February 1, 2017 |
- UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States - University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States - Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States - (and 75 more...)
|
|
| 51 |
NCT02931071 |
Unknown † |
Clinical Phase II Trial to Evaluate CD34+ Cells Mobilization and Collection in Patients With Fanconi Anemia for Subsequent Transduction With a Lentiviral Vector Carring FANCA Gene. FANCOSTEM-1 |
|
- Drug: filgrastim
- Drug: plerixafor
|
Interventional
|
Phase 2 |
- Hospital Universitari Vall d'Hebron Research Institute
- CIEMAT
- CIBERER
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Toxicity of the mobilization procedure according to National Cancer Institute (CTC NCI, versión 3.0)
- Percentage of patients that reach >5 CD34+ cells/mcl after treatment with filgrastim and plerixafor
- Percentage of patients that reach a total CD34+ yield >4x10E6/kg, using the estimated weight of the patient in 5 years
- (and 2 more...)
|
10 |
All |
2 Years to 64 Years (Child, Adult) |
NCT02931071 |
FANCOSTEM-1
2011-006197-88 |
|
September 2013 |
September 2018 |
September 2018 |
October 12, 2016 |
October 12, 2016 |
|
- Hospital Universitari Vall d'Hebron
Barcelona, Spain - Hospital Infantil Universitario Niño Jesus
Madrid, Spain
|
|
| 52 |
NCT00809549 |
Unknown † |
Study to Determine The Effect of a Drug Called Neupogen on Stroke Recovery |
|
|
Interventional
|
Phase 1 |
- Ottawa Hospital Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- A statistically significant increase in: mortality/ non-fatal grade III or greater adverse events measured by the NCI Common Toxicity Scale/ incidence of recurrent strokes/ worsening of neurological disabilities measured by standardized stroke scales.
- The secondary endpoints address the feasibility and efficacy of the study treatment: adequacy of bone marrow cell mobilization/ validation of imaging sequences/ Identification of optimal parameters for follow-up to be used in a subsequent larger trial.
|
20 |
All |
45 Years to 85 Years (Adult, Older Adult) |
NCT00809549 |
2006076-01H |
GIST |
July 2006 |
April 2013 |
April 2013 |
December 17, 2008 |
July 13, 2012 |
|
- The Ottawa Hospital
Ottawa, Ontario, Canada - Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
|
|
| 53 |
NCT00004055 |
Completed |
Topotecan, Paclitaxel, and Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer |
|
- Biological: filgrastim
- Drug: paclitaxel
- Drug: topotecan hydrochloride
|
Interventional
|
Phase 2 |
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
38 |
All |
18 Years and older (Adult, Older Adult) |
NCT00004055 |
NCCTG-982052
CDR0000067251 |
|
November 1999 |
July 2004 |
July 2004 |
June 3, 2004 |
July 13, 2016 |
|
- CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States - CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States - CCOP - Carle Cancer Center
Urbana, Illinois, United States - (and 16 more...)
|
|
| 54 |
NCT00002501 |
Completed |
Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma |
|
- Biological: filgrastim
- Drug: cyclophosphamide
|
Interventional
|
Phase 2 |
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
29 |
All |
18 Years to 55 Years (Adult) |
NCT00002501 |
CALGB-9150
CLB-9150
CDR0000077861 |
|
October 1992 |
July 2001 |
January 2006 |
April 22, 2004 |
July 1, 2016 |
|
- University of Chicago Cancer Research Center
Chicago, Illinois, United States - University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States - Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States - (and 12 more...)
|
|
| 55 |
NCT01569087 |
Completed
Has Results |
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer |
- Chemotherapy-induced Neutropenia
|
- Biological: empegfilrastim
- Biological: filgrastim
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- CTCAE Grade 3/4 Neutropenia Incidence
- Mean Duration of CTCAE Grade 4 Neutropenia
- The Duration of Any Grade Neutropenia
- (and 3 more...)
|
60 |
Female |
18 Years to 70 Years (Adult, Older Adult) |
NCT01569087 |
BCD-017-2 |
|
May 2012 |
January 2013 |
February 2013 |
April 2, 2012 |
December 5, 2016 |
October 24, 2016 |
- Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, Russian Federation - Perm Region Oncology Dispensary
Perm, Russian Federation - N.N.Petrov Oncology Research Center
St.Petersburg, Russian Federation - (and 2 more...)
|
|
| 56 |
NCT02816112 |
Recruiting |
Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia |
- Early Stage Breast Cancer
|
- Drug: Ciprofloxacin
- Drug: Neupogen
|
Interventional
|
Phase 4 |
- Ottawa Hospital Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Febrile neutropenia
- Treatment-related hospitalization
- Chemotherapy dose reduction
- (and 3 more...)
|
176 |
All |
19 Years and older (Adult, Older Adult) |
NCT02816112 |
OTT 16-03 |
REaCT-TC2 |
September 2016 |
August 2019 |
August 2020 |
June 28, 2016 |
March 28, 2019 |
|
- The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
|
|
| 57 |
NCT01908621 |
Completed |
Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Multiple Myeloma Patients. |
|
- Drug: G-CSF (filgrastim)
- Drug: Cytosine arabinoside + G-CSF (filgrastim)
|
Interventional
|
Phase 3 |
- Maria Sklodowska-Curie Institute - Oncology Center
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The proportion of patients with stem cell yield at least 5 × 10^6 CD34+ cells/kg in each treatment arm.
- Peak level of CD34+ cells in peripheral blood (/μl).
- Total number of harvested CD34+cells/kg.
- (and 6 more...)
|
90 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01908621 |
MMMobil-COI-01 |
|
March 20, 2013 |
March 18, 2016 |
October 27, 2017 |
July 25, 2013 |
August 28, 2018 |
|
- Department of Bone Marrow Transplantation and Oncohematology, Maria Sklodowska-Curie Institute, Oncology Center, Gliwice Branch
Gliwice, Poland
|
|
| 58 |
NCT00001071 |
Completed |
A Study of Stem Cells and Filgrastim |
|
|
Interventional
|
Not Applicable |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Primary Purpose: Treatment
|
|
24 |
All |
18 Years and older (Adult, Older Adult) |
NCT00001071 |
ACTG 285
11261 |
|
|
|
October 1998 |
August 31, 2001 |
May 23, 2012 |
|
- UCLA CARE Center CRS
Los Angeles, California, United States - University of Colorado Hospital CRS
Aurora, Colorado, United States
|
|
| 59 |
NCT01408043 |
Terminated |
Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma |
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Grade III Lymphomatoid Granulomatosis
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- (and 31 more...)
|
- Drug: plerixafor
- Biological: filgrastim
- Drug: etoposide
- Procedure: leukapheresis
|
Interventional
|
Not Applicable |
- Case Comprehensive Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Improvement of collection of greater than or equal to 8 x 10^6 CD34+ cells/kg by 25% using plerixafor, etoposide, and filgrastim
- Improvement of progression-free survival of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim
- Improvement of survival of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastim
- (and 4 more...)
|
25 |
All |
18 Years to 78 Years (Adult, Older Adult) |
NCT01408043 |
CASE2410
NCI-2011-01281
P30CA043703 |
|
October 2011 |
May 2016 |
May 2016 |
August 3, 2011 |
December 7, 2016 |
|
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
|
|
| 60 |
NCT00596479 |
Completed |
Filgrastim for the Promotion of Collateral Growth in Patients With CAD |
|
- Drug: Filgrastim (rG-CSF)
|
Interventional
|
Not Applicable |
- University Hospital Inselspital, Berne
- Swiss National Science Foundation
- Swiss Heart Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Collateral flow index (CFI) at 2 weeks follow-up compared to baseline CFI
- Absolute myocardial perfusion during hyperemia by contrast echocardiography (MCE) at baseline, at 2 weeks and at 6 month follow-up
|
50 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT00596479 |
05/04 |
|
November 2004 |
December 2007 |
December 2007 |
January 17, 2008 |
June 16, 2015 |
|
- University Hospital Bern
Bern, Switzerland
|
|
| 61 |
NCT02112045 |
Active, not recruiting
Has Results |
A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation |
|
- Drug: Granix
- Drug: High dose melphalan (HDR)
- Procedure: Autologous Stem Cell Transplant (ASCT)
|
Interventional
|
Phase 2 |
- Washington University School of Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Complete Response or Stringent Complete Response
- Number of Participants With Adverse Events
- Number of Participants With Overall Response
- (and 4 more...)
|
90 |
All |
18 Years and older (Adult, Older Adult) |
NCT02112045 |
201405057 |
|
January 20, 2015 |
December 13, 2017 |
September 5, 2019 |
April 11, 2014 |
January 7, 2019 |
January 7, 2019 |
- Washington University School of Medicine
Saint Louis, Missouri, United States
|
|
| 62 |
NCT02104830 |
Completed
Has Results |
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients |
- Chemotherapy-induced Neutropenia
|
- Biological: Empegfilrastim 6 mg
- Biological: Filgrastim
- Biological: Placebo №1
- (and 2 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Supportive Care
|
- Duration of Neutropenia CTCAE Grade 4
- The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);
- The Incidence of Severe Neutropenia (Grade 3-4)
- (and 3 more...)
|
135 |
Female |
18 Years to 70 Years (Adult, Older Adult) |
NCT02104830 |
BCD-017-3 |
|
September 2013 |
June 2014 |
October 2014 |
April 4, 2014 |
October 24, 2016 |
October 24, 2016 |
- Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, Russian Federation - Clinical Hospital at Chelyabinsk Railway Station
Chelyabinsk, Russian Federation - State public health institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of the Republic of Tatarstan
Kazan, Russian Federation - (and 10 more...)
|
|
| 63 |
NCT01149096 |
Terminated |
Collection of Bone Marrow From Donors Treated With or Without Filgrastim |
- Healthy Stem Cell Donor
- Healthy, no Evidence of Disease
|
- Biological: filgrastim
- Procedure: bone marrow donation
- Other: laboratory biomarker analysis
|
Observational
|
|
- Children's Oncology Group
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Incidence of short-term adverse events in G-CSF stimulated-bone marrow (G-BM) donors, graded according to the Cancer Therapy Evaluation Program (CTEP) Active Version of the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading scale
- 10-year mortality and cancer risk in marrow donors
|
13 |
All |
Child, Adult, Older Adult |
NCT01149096 |
ASCT0631D
NCI-2011-02237
COG-ASCT0631D
U10CA098543 |
|
June 2010 |
December 2011 |
December 2011 |
June 23, 2010 |
February 9, 2017 |
|
- University of California San Francisco Medical Center-Parnassus
San Francisco, California, United States - Children's Hospital Colorado
Aurora, Colorado, United States - Lurie Children's Hospital-Chicago
Chicago, Illinois, United States - (and 15 more...)
|
|
| 64 |
NCT00215124 |
Completed |
A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction |
- Acute Myocardial Infarction
|
|
Interventional
|
Phase 1
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single
- Primary Purpose: Treatment
|
- Death or myocardial rupture at 30 days; change in left ventricular ejection fraction from baseline to 30 days
- i) Survival through 12 months ii) Re-hospitalization for CHF through 12 months iii) Improvement in LVEF at days 7 and 12 months iv) Infarct wall thickness at 30 days v) Re-infarction within 30 days v
|
|
All |
18 Years and older (Adult, Older Adult) |
NCT00215124 |
5225 |
|
|
|
February 2007 |
September 22, 2005 |
September 19, 2008 |
|
- Cleveland Clinic Foundation
Cleveland, Ohio, United States
|
|
| 65 |
NCT00003929 |
Withdrawn |
Chemotherapy, Filgrastim, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma |
|
- Biological: filgrastim
- Drug: lomustine
- Drug: procarbazine hydrochloride
- Radiation: radiation therapy
|
Interventional
|
Phase 2 |
- Case Comprehensive Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Effectiveness of lomustine, procarbazine, filgrastim, and radiation therapy in treating patients who have primary central nervous system lymphoma.
|
0 |
All |
Child, Adult, Older Adult |
NCT00003929 |
CWRU3496
P30CA043703
CWRU-3496
CWRU-AMC-2A-93
NCI-G99-1533 |
|
June 1998 |
March 2000 |
|
July 26, 2004 |
March 20, 2012 |
|
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
|
|
| 66 |
NCT00041067 |
Completed
Has Results |
S0215 Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer |
|
- Biological: filgrastim
- Biological: trastuzumab
- Drug: docetaxel
- Drug: vinorelbine
|
Interventional
|
Phase 2 |
- Southwest Oncology Group
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Survival at 1 Year
- Response Rate (Complete and Partial, Confirmed and Unconfirmed)
- Progression-free Survival
- Toxicity
|
76 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00041067 |
CDR0000069440
S0215
U10CA032102 |
|
September 2002 |
January 2008 |
January 2012 |
January 27, 2003 |
June 6, 2013 |
June 6, 2013 |
- Mobile Infirmary Medical Center
Mobile, Alabama, United States - Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Ft. Smith, Arkansas, United States - Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center
Jonesboro, Arkansas, United States - (and 142 more...)
|
|
| 67 |
NCT00002126 |
Completed |
A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection. |
|
|
Interventional
|
Phase 2 |
- Amgen
- NIH AIDS Clinical Trials Information Service
|
Industry |
- Primary Purpose: Treatment
|
|
250 |
All |
13 Years and older (Child, Adult, Older Adult) |
NCT00002126 |
087A
GCSF-930101 |
|
|
|
|
August 31, 2001 |
June 24, 2005 |
|
- Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham, Alabama, United States - Maricopa County Med Ctr
Phoenix, Arizona, United States - CARE Ctr / UCLA Med Ctr
Los Angeles, California, United States - (and 19 more...)
|
|
| 68 |
NCT02725086 |
Completed |
Evaluation of Pharmacokinetic/Pharmacodynamic Properties and Safety of Leucostim® Compared to Neupogen® in Healthy Adult Volunteers |
|
- Drug: Leucostim®
- Drug: Neupogen®
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- AUCinf of Filgrastim
- Cmax of Filgrastim
- AUEC0-t of ANC(absolute neutrophil count)
- (and 7 more...)
|
56 |
Male |
19 Years to 45 Years (Adult) |
NCT02725086 |
DA3030_NP_I |
|
February 2016 |
April 2016 |
May 2016 |
March 31, 2016 |
November 10, 2016 |
|
- Severance Hospital, Yonsei University College of Medicine
Seoul, Seodamun-gu, Korea, Republic of
|
|
| 69 |
NCT00004853 |
Completed |
Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts After Intensive Chemotherapy |
- Ewing's Sarcoma
- Rhabdomyosarcoma
- MPNST
- (and 2 more...)
|
- Biological: Filgrastim
- Biological: Filgrastim-SD/01
|
Interventional
|
Phase 1 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Tolerance and toxicity
- PKs
- Compare neutrophil function
- (and 5 more...)
|
34 |
All |
up to 25 Years (Child, Adult) |
NCT00004853 |
000092
00-C-0092 |
|
March 3, 2000 |
May 20, 2009 |
May 20, 2009 |
March 6, 2000 |
May 8, 2019 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 70 |
NCT01016795 |
Terminated |
Stem Cell Factor (SCF) Priming of Haematopoietic Stem Cell Grafts in Malignant Lymphoma |
|
- Drug: r-metHuSCF and Filgrastim
- Drug: Chemotherapy plus Filgrastim
|
Interventional
|
Phase 2 |
- Aalborg University Hospital
- Herlev Hospital
- Rigshospitalet, Denmark
- (and 7 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Safety and Toxicity was assessed by morbidity, including unexpected adverse events associated with the priming and the transplantation phases during study, and measured and graded by CTC criteria.
- To compare the time dependent level of blood circulating and harvested haematopoietic stem cells and progenitors (PBSC) in patients treated with either a combination of r-metHuSCF and Filgrastim, or conventional chemotherapy plus Filgrastim.
|
32 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01016795 |
SCF 980266
H-KA-99040-GMS |
SCF980266 |
January 1999 |
November 2000 |
November 2009 |
November 20, 2009 |
June 25, 2015 |
|
- Aalborg Hospital
Aalborg, Denmark - Rigshospitalet
Copenhagen, Denmark - Herlev University Hospital
Copenhagen, Denmark - (and 5 more...)
|
|
| 71 |
NCT02703051 |
Completed |
A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects |
|
- Drug: GMI-1271
- Drug: Filgrastim
- Drug: Placebo Injection
- Drug: Placebo Infusion
|
Interventional
|
Phase 1 |
- GlycoMimetics Incorporated
- Celerion
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Participant)
- Primary Purpose: Other
|
- Measurement of subsets of WBC
- Number of adverse events as a measure of safety and tolerability
|
54 |
All |
19 Years to 60 Years (Adult) |
NCT02703051 |
GMI-1271-103 |
|
November 2015 |
August 2016 |
August 2016 |
March 9, 2016 |
February 27, 2018 |
|
- Celerion
Lincoln, Nebraska, United States
|
|
| 72 |
NCT02408991 |
Withdrawn |
Use Art-assist and Neupogen to Treat Chronic Limb Ischemia |
|
- Drug: Neupogen
- Device: Art-Assist Device
|
Interventional
|
Phase 4 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Measuring the pharmacologic increase in of CD31+ (mature endothelial cell)
- Measureing the pharmacologic increase in CD34+(progenitor cell),
- Measureing the pharmacologic increase in VEGFR2+ (endothelial progenitor cell)
- Pharmacologix measurement of nitrite
|
0 |
All |
40 Years to 85 Years (Adult, Older Adult) |
NCT02408991 |
IRB14-0553 |
|
September 2014 |
July 2015 |
July 2015 |
April 6, 2015 |
April 8, 2016 |
|
- University of Chicago
Chicago, Illinois, United States
|
|
| 73 |
NCT03740464 |
Recruiting |
Long-acting G-CSF for Febrile Neutropenia |
- Epithelial Ovarian Cancer
- Colony Stimulating Factors
- Febrile Neutropenia
- (and 3 more...)
|
- Drug: long-acting granulocyte colony stimulating factor
- Drug: Short-term granulocyte colony stimulating factor
|
Interventional
|
Phase 3 |
- Lei Li
- Peking Union Medical College Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- febrile neutropenia
- myelosuppression
- doses of granulocyte colony stimulating factor
- (and 4 more...)
|
556 |
Female |
18 Years and older (Adult, Older Adult) |
NCT03740464 |
EOC-GCSF |
|
November 10, 2018 |
November 10, 2019 |
November 10, 2023 |
November 14, 2018 |
November 14, 2018 |
|
- Lei Li
Beijing, Beijing, China
|
|
| 74 |
NCT01194934 |
Completed |
NOX-A12 Multiple Ascending Dose Study in Healthy Volunteers |
- Hematopoietic Stem Cell Transplantation
|
- Drug: NOX-A12
- Drug: Filgrastim
- Drug: NOX-A12 in combination with Filgrastim
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the safety and tolerability of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.
- To determine the pharmacokinetics of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.
- To quantify the mobilization of HSCs in peripheral blood after repeated doses of NOX-A12 alone, of filgrastim alone and after the combination of NOX-A12 with filgrastim.
|
12 |
All |
18 Years to 55 Years (Adult) |
NCT01194934 |
SNOXA12C101
2010-020937-14 |
SNOXA12C101 |
August 2010 |
January 2011 |
January 2011 |
September 3, 2010 |
June 26, 2014 |
|
- Charité Research Organisation GmbH
Berlin, Germany
|
|
| 75 |
NCT00030758 |
Unknown † |
Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer |
|
- Biological: filgrastim
- Biological: pegfilgrastim
|
Interventional
|
Phase 4 |
- Anglo Celtic Cooperative Oncology Group
- Scottish Cancer Therapy Network
- National Cancer Institute (NCI)
|
Other |
- Allocation: Randomized
- Primary Purpose: Supportive Care
|
- Proportion of patients achieving ≥ 85% of planned dose intensity
- Proportion of patients with ≥ 1 neutropenic event
- Dose intensity achieved
- Cost of management
|
816 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00030758 |
ACCOG-SCTN-BR0101
CDR0000069195
SCTN-BR0101
EU-20143 |
|
October 2001 |
|
|
January 27, 2003 |
August 7, 2013 |
|
- City Hospital - Birmingham
Birmingham, England, United Kingdom - Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom - Cheltenham General Hospital
Cheltenham, England, United Kingdom - (and 29 more...)
|
|
| 76 |
NCT02331745 |
Unknown † |
RCT Study on Granulocyte Colony-stimulating Factor(G-CSF) Treatment of Hepatic Failure |
- Liver Failure
- Hepatitis B
- Alcoholic Liver Disease
|
- Drug: Granulocyte colony-stimulating factor
- Drug: standard treatment
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Survival rates
- (Model of End Liver Disease,MELD) score
- (Sepsis-related Organ Failure Assessment,SOFA) score
- (and 2 more...)
|
140 |
All |
17 Years to 70 Years (Child, Adult, Older Adult) |
NCT02331745 |
Z131107002213157 |
|
October 2013 |
April 2016 |
October 2016 |
January 6, 2015 |
August 5, 2016 |
|
- Beijing; 302 Military Hospital
Beijing, China
|
|
| 77 |
NCT01455025 |
Terminated |
Study in Plerixafor and Granulocyte-colony Stimulating Factor Patients With Relapse Acute Myeloid Leukemia |
|
- Drug: Plerixafor granulocyte-colony stimulating factor
|
Interventional
|
Phase 1 |
- French Innovative Leukemia Organisation
- Acute Leukemia French Association
- Genzyme, a Sanofi Company
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- maximal tolerated dose
- safety and tolerability of plerixafor in combination with granulocyte-colony stimulating factor and chemotherapy
- Efficacy of plerixafor on leukemic blasts
- Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
|
11 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01455025 |
Primal study |
PRIMAL |
January 2012 |
March 2015 |
August 2015 |
October 19, 2011 |
March 16, 2016 |
|
- Xavier THOMAS
Lyon, France
|
|
| 78 |
NCT00901381 |
Completed |
Granulocyte-colony Stimulating Factor for Stem Cells Therapy for Acute Ischemic Stroke |
|
|
Interventional
|
Phase 2 |
- Clinical Institute of the Brain, Russia
- Institute of Medical Cells Technologies
- City Hospital No 40, Saint Petersburg, Russia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dependence assessed by the modified Rankin scale
- Impairment assessed by the Medical Research Consul scale and National Institutes of Health Stroke Scale
- Disability assessed by the Barthel Index and Glasgow Outcome Scale
- (and 2 more...)
|
20 |
All |
40 Years to 70 Years (Adult, Older Adult) |
NCT00901381 |
GKSF-8 |
STEMTHER |
June 2007 |
February 2009 |
February 2009 |
May 13, 2009 |
January 7, 2014 |
|
- Clinical Institute of the Brain
Ekaterinburg, Russian Federation
|
|
| 79 |
NCT00015938 |
Completed |
S0102: Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer |
|
- Biological: filgrastim
- Drug: docetaxel
- Drug: vinorelbine
|
Interventional
|
Phase 2 |
- Southwest Oncology Group
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
95 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00015938 |
CDR0000068575
S0102
U10CA032102 |
|
May 2001 |
February 2005 |
November 2012 |
January 27, 2003 |
January 24, 2013 |
|
- MBCCOP - Gulf Coast
Mobile, Alabama, United States - Providence Alaska Medical Center
Anchorage, Alaska, United States - CCOP - Western Regional, Arizona
Phoenix, Arizona, United States - (and 96 more...)
|
|
| 80 |
NCT02722733 |
Unknown † |
Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma |
- Hodgkin's Lymphoma
- Non-Hodgkin's Lymphoma
|
- Drug: G-CSF (filgrastim)
- Drug: Cytosine arabinoside with G-CSF (filgrastim)
|
Interventional
|
Phase 3 |
- Maria Sklodowska-Curie Institute - Oncology Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- • The proportion of patients with stem cell yield at least 2 × 10^6 CD34+ cells/kg in each treatment arm.
- Peak level of CD34+ cells in peripheral blood (cells/μl).
- Total number of harvested CD34+cells/kg.
- (and 8 more...)
|
90 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02722733 |
HL/NHLMobil-COI-01 |
|
March 2016 |
March 2017 |
April 2017 |
March 30, 2016 |
March 30, 2016 |
|
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
Gliwice, Poland
|
|
| 81 |
NCT03395028 |
Enrolling by invitation |
GCSF Adjunct Therapy for Biliary Atresia |
|
- Drug: Granulocyte Colony-Stimulating Factor
|
Interventional
|
Early Phase 1 |
- Holterman, Ai-Xuan, M.D.
- T Rose Clinical, Inc.
- Children's National Health System
- Prometheus USA, Ltd. Co.
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
|
6 |
All |
up to 180 Days (Child) |
NCT03395028 |
CR00005169
IND 119679-0007 |
BA_GCSF |
January 15, 2018 |
December 31, 2018 |
January 31, 2019 |
January 9, 2018 |
February 21, 2018 |
|
- Children's National Medical Center
Washington, District of Columbia, United States
|
|
| 82 |
NCT00801489 |
Recruiting |
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome |
- Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
- Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
- Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
- (and 7 more...)
|
- Drug: Cytarabine
- Drug: Decitabine
- Biological: Filgrastim-sndz
- (and 4 more...)
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete remission rate
- Toxicity rate
|
200 |
All |
18 Years and older (Adult, Older Adult) |
NCT00801489 |
2007-0147
NCI-2012-01659
P30CA016672 |
|
April 4, 2007 |
April 30, 2020 |
April 30, 2020 |
December 3, 2008 |
May 24, 2019 |
|
- M D Anderson Cancer Center
Houston, Texas, United States
|
|
| 83 |
NCT03381599 |
Active, not recruiting |
Stem Cells After Peripheral Mobilization and Harvest |
- Stem Cells
- Orthopedic Disorder
|
- Drug: Filgrastim Injection
|
Interventional
|
Phase 1 |
- Andrews Research & Education Foundation
- Auburn University
- Arthrex, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Change in Stem Cell Count
- Complete blood count
- Chemokine/Cytokine
|
10 |
Male |
19 Years to 39 Years (Adult) |
NCT03381599 |
16398 |
|
March 28, 2018 |
May 2019 |
December 2019 |
December 22, 2017 |
May 24, 2019 |
|
- Auburn University
Auburn, Alabama, United States
|
|
| 84 |
NCT00306111 |
Completed |
Pegfilgrastim vs. Filgrastim - Comparison of Mobilized Blood Stem Cells in Patients With Non Hodgkin-lymphoma |
|
|
Interventional
|
Phase 2 |
- University Hospital Tuebingen
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Hematopoietic recovery after autologous stem cell transplantation
- Intraindividual comparison of quantity/quality of circulating stem cells
|
14 |
All |
18 Years and older (Adult, Older Adult) |
NCT00306111 |
rpm_001 |
|
January 2006 |
December 2008 |
December 2011 |
March 22, 2006 |
May 29, 2014 |
|
- Dept. of Medicine 2, University of Tuebingen
Tuebingen, BW, Germany
|
|
| 85 |
NCT03945812 |
Not yet recruiting
New |
Granulocyte Colony Stimulating Factor Versus Platelet Rich Plasma and Outcomes of Frozen Embryo Transfer |
|
- Drug: Granulocyte Colony Stimulating Factor
- Other: Platelet Rich Plasma Arm
- Other: Saline
|
Interventional
|
Phase 4 |
- ClinAmygate
- Wael El-Banna Clinic Cairo Egypt
- National Research Center, Egypt
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The clinical pregnancy rate
- Chemical pregnancy rate
- endometrial thickness
- (and 3 more...)
|
390 |
Female |
20 Years to 40 Years (Adult) |
NCT03945812 |
INDV-0909012 |
|
May 15, 2019 |
November 15, 2019 |
November 15, 2020 |
May 10, 2019 |
May 14, 2019 |
|
|
|
| 86 |
NCT00117455 |
Completed |
A Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim in Subjects With Non-Hodgkin's Lymphoma |
|
- Drug: pegfilgrastim
- Drug: filgrastim
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Adequate collection of PBPC's to enable transplant following high dose chemotherapy
- Time to engraftment post-transplant
|
|
All |
18 Years and older (Adult, Older Adult) |
NCT00117455 |
20020113 |
|
|
|
|
July 7, 2005 |
May 16, 2008 |
|
|
|
| 87 |
NCT01182675 |
Terminated
Has Results |
Hematopoietic Stem Cell Transplantation (HSCT) for Children With SCID Utilizing Alemtuzumab, Plerixafor & Filgrastim |
- Severe Combined Immunodeficiency
|
- Drug: Transplant Conditioning with Mobilization Only
- Drug: Transplant Conditioning with Mobilization and Alemtuzumab
|
Interventional
|
Phase 2 |
- University of California, San Francisco
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Engraftment of Donor B-cells in Blood by STR Testing
- Incidence of Acute GVHD
- Incidence of Chronic GVHD
- (and 3 more...)
|
7 |
All |
up to 3 Years (Child) |
NCT01182675 |
UCSF10-00701 |
|
August 2010 |
September 2013 |
September 2013 |
August 17, 2010 |
July 31, 2018 |
November 10, 2014 |
- UCSF Benioff Children's Hospital
San Francisco, California, United States
|
|
| 88 |
NCT02802852 |
Unknown † |
Proteomics and Stem Cell Therapy as a New Vascularization Strategy |
|
- Device: Pneumatic calf compression
- Drug: Filgrastim
|
Interventional
|
Not Applicable |
- University of Illinois at Chicago
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Hepatocyte Growth Factor
- Insulin Growth Factor
- Vascular Endothelial Growth Factor A
- (and 22 more...)
|
25 |
All |
35 Years to 85 Years (Adult, Older Adult) |
NCT02802852 |
2015-1244 |
|
June 2016 |
March 2017 |
March 2017 |
June 16, 2016 |
June 16, 2016 |
|
- University of Illinois at Chicago
Chicago, Illinois, United States
|
|
| 89 |
NCT03498248 |
Recruiting |
Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF) |
|
|
Interventional
|
Not Applicable |
- DERSHENG SUN
- The Catholic University of Korea
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- duration of severe neutropenia
|
155 |
All |
Child, Adult, Older Adult |
NCT03498248 |
Granulocyte-Colony Stimulating |
|
February 19, 2018 |
August 31, 2018 |
August 31, 2019 |
April 13, 2018 |
April 13, 2018 |
|
- the Catholic university of Korea
Seoul, Gyounggido, Korea, Republic of
|
|
| 90 |
NCT01549301 |
Completed |
Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A. |
|
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary efficacy parameters will be based on the investigation of pharmacokinetics and pharmacodynamics of filgrastim in research subjects after administration of single dose via sc or iv routes at doses of 5 or 10 mcg/kg of the drug.
|
128 |
All |
18 Years to 50 Years (Adult) |
NCT01549301 |
FILBLA1211I
Version 01 - 09/12/2011 |
|
August 2012 |
August 2013 |
September 2013 |
March 9, 2012 |
June 20, 2018 |
|
- LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil
|
|
| 91 |
NCT02428114 |
Completed |
A Multi Centre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (React-G Study) |
- Early Stage Breast Cancer
|
|
Observational
|
|
- Ottawa Hospital Research Institute
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Feasibility of performing this study will be measured with composite endpoints: physician engagement, time for local or provincial research ethics approval, accrual rates, and patient/physician compliance.
- Rates of documented febrile neutropenia (laboratory confirmation)
- ANC results at the end of each cycle of chemotherapy.
- (and 3 more...)
|
142 |
All |
19 Years and older (Adult, Older Adult) |
NCT02428114 |
OTT 14-05 |
React-G |
May 2015 |
March 2017 |
March 2017 |
April 28, 2015 |
September 29, 2017 |
|
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada - The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
|
|
| 92 |
NCT03823950 |
Recruiting |
Starting Granulocyte Colony-Stimulating Factor at 1 Day vs 3 Days Following Chemotherapy in Pediatric Cancer Patients |
- Granulocyte Colony-Stimulating Factor
- Chemotherapy-induced Neutropenia
- Chemotherapy-Induced Febrile Neutropenia
- Pediatric Cancer
|
- Drug: Granulocyte Colony-Stimulating Factor
|
Interventional
|
Phase 4 |
- University of Mississippi Medical Center
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Incidence of hospital admissions for febrile neutropenia
- Duration of neutropenia
- Days delayed in beginning the next course of chemotherapy
|
150 |
All |
up to 21 Years (Child, Adult) |
NCT03823950 |
2018-0082 |
|
February 1, 2019 |
December 2019 |
December 2019 |
January 31, 2019 |
February 11, 2019 |
|
- Univeristy of Mississippi Medical Center
Jackson, Mississippi, United States
|
|
| 93 |
NCT00511550 |
Completed |
Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors |
|
|
Observational
|
|
- University of California, San Francisco
|
Other |
- Time Perspective: Prospective
|
|
15 |
All |
18 Years to 60 Years (Adult) |
NCT00511550 |
UC-2508 |
|
August 2005 |
|
November 2007 |
August 6, 2007 |
March 5, 2008 |
|
- University of California San Francisco Medical Center
San Francisco, California, United States
|
|
| 94 |
NCT00820976 |
Completed |
Induction With or Without Granulocyte Colony-Stimulating Factor in AML Transplantation in AML |
|
|
Interventional
|
Phase 3 |
- Turkish Leukemia Study Group
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- response to induction
- overall survival
|
260 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT00820976 |
TLG-AML-95-002 |
TLG-AML-95-002 |
March 1996 |
March 2000 |
January 2009 |
January 12, 2009 |
January 12, 2009 |
|
|
|
| 95 |
NCT02044796 |
Active, not recruiting |
Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes |
- Acute Biphenotypic Leukemia
- de Novo Myelodysplastic Syndrome
- Previously Treated Myelodysplastic Syndrome
- (and 3 more...)
|
- Drug: Cladribine
- Drug: Cytarabine
- Biological: Filgrastim
- (and 2 more...)
|
Interventional
|
Phase 1
Phase 2 |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose of mitoxantrone, defined as the highest dose studied in which the incidence of dose-limiting toxicity is < 33%, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
- Minimal residual disease negative complete remission rate in patients with newly diagnosed disease (Phase II)
- Overall survival rate (Phase II expansion cohort)
- Remission rate (complete remission and complete remission with incomplete platelet count recovery) of this regimen in patients with relapsed/refractory disease (Phase II)
|
199 |
All |
18 Years and older (Adult, Older Adult) |
NCT02044796 |
2734.00
NCI-2013-02465
P30CA015704 |
|
January 23, 2014 |
March 9, 2018 |
August 1, 2022 |
January 24, 2014 |
May 30, 2018 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
|
| 96 |
NCT00002836 |
Completed |
Filgrastim Plus Chemotherapy Compared With Filgrastim Alone In Treating Women Undergoing Peripheral Stem Cell Transplantation For Breast Cancer |
|
- Biological: Filgrastim (G-CSF)
- Drug: Carmustine
- Drug: Cisplatin
- (and 4 more...)
|
Interventional
|
Phase 3 |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Compare Effectiveness of Chemotherapy + Filgrastim to Filgrastim Alone
|
184 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00002836 |
DM95-047
P30CA016672
MDA-DM-95047
NCI-G96-1014
CDR0000065048 |
|
September 26, 1995 |
March 9, 2006 |
March 9, 2006 |
November 24, 2003 |
November 6, 2018 |
|
- University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 97 |
NCT00028925 |
Completed |
Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer |
|
- Biological: filgrastim
- Drug: carboplatin
- Drug: topotecan hydrochloride
- Radiation: WBRT
|
Interventional
|
Phase 2 |
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- response rate
- overall survival
|
27 |
All |
18 Years and older (Adult, Older Adult) |
NCT00028925 |
NCCTG-N0027
NCI-2012-02441
CDR0000069147 |
|
November 2001 |
November 2005 |
August 2008 |
June 30, 2003 |
December 7, 2016 |
|
- CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States - MBCCOP-Howard University Cancer Center
Washington, District of Columbia, United States - Mayo Clinic
Jacksonville, Florida, United States - (and 21 more...)
|
|
| 98 |
NCT00959777 |
Completed |
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating DA-3031 (PEG-G-CSF) to Filgrastim (Dong-A) in Healthy Volunteers |
|
- Drug: DA-3031
- Drug: Filgrastim
|
Interventional
|
Phase 1 |
|
Industry |
|
|
|
Male |
20 Years to 40 Years (Adult) |
NCT00959777 |
DA3031_NP_I |
|
|
|
|
August 17, 2009 |
October 1, 2014 |
|
- Clinical Trials center, Clinical Research institute, Seoul National University Hospital
Seoul, Yonggon-Dong, Chongono-Gu, Korea, Republic of
|
|
| 99 |
NCT00005958 |
Unknown † |
Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer |
- Bladder Cancer
- Transitional Cell Cancer of the Renal Pelvis and Ureter
|
- Biological: filgrastim
- Drug: docetaxel
- Drug: gemcitabine hydrochloride
|
Interventional
|
Phase 2 |
- Amgen
- National Cancer Institute (NCI)
|
Industry |
- Primary Purpose: Treatment
|
|
|
All |
18 Years and older (Adult, Older Adult) |
NCT00005958 |
CDR0000067939
AMGEN-GCSF-990125
NCI-V00-1594 |
|
October 1999 |
|
|
April 20, 2004 |
December 4, 2013 |
|
- University of California San Diego
La Jolla, California, United States - Sacramento Center for Hematology and Medical Oncology
Sacramento, California, United States - Washington Cancer Institute
Washington, District of Columbia, United States - (and 9 more...)
|
|
| 100 |
NCT00035620 |
Completed |
Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy |
|
- Drug: pegfilgrastim
- Drug: filgrastim
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Duration of severe neutropenia in chemotherapy in cycles 1 and 3
- Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3
- Pharmacokinetic profile in chemotherapy cycles 1 and 3
- (and 2 more...)
|
44 |
All |
up to 21 Years (Child, Adult) |
NCT00035620 |
990130 |
|
April 2000 |
January 2007 |
April 2007 |
May 6, 2002 |
February 26, 2010 |
|
|
|
Create an RSS feed from your search for:
Download the search results for: