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Trial record 13 of 23 for:    CD20 Fred Hutchinson

Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01097057
Recruitment Status : Completed
First Posted : April 1, 2010
Results First Posted : July 2, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Leona Holmberg, Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE March 30, 2010
First Posted Date  ICMJE April 1, 2010
Results First Submitted Date  ICMJE March 26, 2017
Results First Posted Date  ICMJE July 2, 2017
Last Update Posted Date January 23, 2018
Actual Study Start Date  ICMJE November 9, 2010
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
  • Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy) [ Time Frame: One Month ]
    Number of patients who achieved ≥5 x 10^6 CD34 cells/kg autologous PBSC collection by apheresis.
  • Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days [ Time Frame: Up to Four Apheresis Days ]
    Number of patients to collect at least 5 x 10^6 CD34 cells/kg in under 4 apheresis procedures.
  • Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg [ Time Frame: Up to Four Apheresis Days ]
    Number of participants requiring one or two apheresis collection days to reach collection goal.
  • Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days [ Time Frame: Up to Four Apheresis Days ]
    Number of participants who did not collect ≥5 x 10^6 CD34 cells/kg in up to four apheresis days
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
Ability to mobilize an adequate number of autologous PBSC [ Time Frame: 3 years ]
Change History Complete list of historical versions of study NCT01097057 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
  • Toxicity assessed by NCI CTCAE v3.0 [ Time Frame: 3 years ]
  • Engraftment after transplant as assessed by initial neutrophil recovery [ Time Frame: 30 days ]
  • Delayed platelet engraftment after transplant [ Time Frame: 100 days ]
  • Secondary graft failure [ Time Frame: 12 months ]
  • Tumor status [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells
Official Title  ICMJE Mobilization of Autologous Peripheral Blood Stem Cells (PBSC) in CD20+ Lymphoma Patients Using RICE, G-CSF (Granulocyte-Colony Stimulating Factor), and Plerixafor
Brief Summary This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells. Giving chemotherapy (ICE) with monoclonal antibodies, such as rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them and helps get better autologous stem cell product. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for future autologous transplant.
Detailed Description

OBJECTIVES:

I. Evaluate the efficacy of combining RICE (rituximab-ifosfamide-carboplatin-etoposide regimen [R-ICE regimen]), G-CSF, and plerixafor to collect autologous peripheral blood stem cell (PBSC) for non-Hodgkin's lymphoma (NHL) patients by: the number of days of apheresis required to reach >= 5 x 10^6 cluster of differentiation (CD)34 cells/kg and by the total number of CD34 cells/kg collected in a maximum of 4 days if >= 5 x 10^6 CD34 cells/kg is not obtained.

OUTLINE:

Patients receive rituximab intravenously (IV) on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive filgrastim subcutaneously (SC) once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.

After completion of study treatment, patients are followed up at 30 days and then periodically for up to 12 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Hodgkin Lymphoma
Intervention  ICMJE
  • Drug: Carboplatin
    Given IV
    Other Names:
    • Blastocarb
    • Carboplat
    • Carboplatin Hexal
    • Carboplatino
    • Carbosin
    • Carbosol
    • Carbotec
    • CBDCA
    • Displata
    • Ercar
    • JM-8
    • Nealorin
    • Novoplatinum
    • Paraplat
    • Paraplatin
    • Paraplatin AQ
    • Paraplatine
    • Platinwas
    • Ribocarbo
  • Drug: Etoposide
    Given IV
    Other Names:
    • Demethyl Epipodophyllotoxin Ethylidine Glucoside
    • EPEG
    • Lastet
    • Toposar
    • Vepesid
    • VP 16-213
    • VP-16
    • VP-16-213
  • Biological: Filgrastim
    Given SC
    Other Names:
    • Filgrastim XM02
    • G-CSF
    • Neupogen
    • r-metHuG-CSF
    • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
    • rG-CSF
    • Tbo-filgrastim
    • Tevagrastim
  • Drug: Ifosfamide
    Given IV
    Other Names:
    • Asta Z 4942
    • Asta Z-4942
    • Cyfos
    • Holoxan
    • Holoxane
    • Ifex
    • IFO
    • IFO-Cell
    • Ifolem
    • Ifomida
    • Ifomide
    • Ifosfamidum
    • Ifoxan
    • IFX
    • Iphosphamid
    • Iphosphamide
    • Iso-Endoxan
    • Isoendoxan
    • Isophosphamide
    • Mitoxana
    • MJF 9325
    • MJF-9325
    • Naxamide
    • Seromida
    • Tronoxal
    • Z 4942
    • Z-4942
  • Procedure: Leukapheresis
    Given through catheter
    Other Names:
    • Leukocytopheresis
    • Therapeutic Leukopheresis
  • Drug: Plerixafor
    Given SC
    Other Names:
    • AMD 3100
    • JM-3100
    • Mozobil
    • SDZ SID 791
  • Biological: Rituximab
    Given IV
    Other Names:
    • BI 695500
    • C2B8 Monoclonal Antibody
    • Chimeric Anti-CD20 Antibody
    • IDEC-102
    • IDEC-C2B8
    • IDEC-C2B8 Monoclonal Antibody
    • MabThera
    • Monoclonal Antibody IDEC-C2B8
    • PF-05280586
    • Rituxan
    • Rituximab Biosimilar BI 695500
    • Rituximab Biosimilar PF-05280586
    • Rituximab Biosimilar RTXM83
    • RTXM83
Study Arms  ICMJE Experimental: Treatment (rituximab, etoposide, carboplatin, ifosfamide)
Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Interventions:
  • Drug: Carboplatin
  • Drug: Etoposide
  • Biological: Filgrastim
  • Drug: Ifosfamide
  • Procedure: Leukapheresis
  • Drug: Plerixafor
  • Biological: Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 26, 2017
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of CD20+ non-Hodgkin's lymphoma
  • Left ventricular ejection fraction at rest >= 50% demonstrated by multi gated acquisition scan (MUGA) or echocardiogram
  • Bilirubin =< 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 times the upper limit of normal
  • Creatinine clearance (calculated creatinine clearance is permitted) > 50 mL/min
  • Signed informed consent
  • Planned autologous transplant within 3 months after collection of peripheral blood stem cells (PBSCs)

Exclusion Criteria:

  • Karnofsky performance score < 70%
  • Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
  • Prior other malignancies except resected basal cell carcinoma or treated cervical carcinoma or breast cancer in situ; cancer treated with curative intent > 5 years previously will be allowed
  • Pregnant or breastfeeding
  • Fertile men or women unwilling to use contraceptive techniques from the time of chemo-mobilization
  • Prior autologous or allogeneic hematopoietic stem cell transplant (HSCT)
  • Human immunodeficiency virus (HIV) positive
  • Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study
  • Hepatitis B carriers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01097057
Other Study ID Numbers  ICMJE 2310.00
NCI-2009-01562 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2310.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Leona Holmberg, Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Leona Holmberg Fred Hutch/University of Washington Cancer Consortium
PRS Account Fred Hutchinson Cancer Research Center
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP