ClinicalTrials.gov

History of Changes for Study: NCT02598661
Study to Evaluate Imetelstat (GRN163L) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Latest version (submitted September 8, 2020) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 November 4, 2015 None (earliest Version on record)
2 November 25, 2015 Contacts/Locations, Oversight and Study Status
3 November 30, 2015 Recruitment Status, Contacts/Locations, Study Status and References
4 December 22, 2015 Contacts/Locations and Study Status
5 January 20, 2016 Contacts/Locations and Study Status
6 February 10, 2016 Contacts/Locations and Study Status
7 March 3, 2016 Contacts/Locations and Study Status
8 March 24, 2016 Contacts/Locations and Study Status
9 April 14, 2016 Contacts/Locations and Study Status
10 May 4, 2016 Study Status and Contacts/Locations
11 May 25, 2016 Contacts/Locations and Study Status
12 June 22, 2016 Outcome Measures, Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Study Description and Oversight
13 July 13, 2016 Contacts/Locations and Study Status
14 August 4, 2016 Contacts/Locations and Study Status
15 September 21, 2016 Contacts/Locations and Study Status
16 October 21, 2016 Study Status and Contacts/Locations
17 November 18, 2016 Study Status and Contacts/Locations
18 January 13, 2017 Study Status and Contacts/Locations
19 April 6, 2017 Study Status, Contacts/Locations and Oversight
20 June 29, 2017 Contacts/Locations, Oversight and Study Status
21 July 27, 2017 Contacts/Locations, Study Status and Oversight
22 August 24, 2017 Study Status and Contacts/Locations
23 September 29, 2017 Outcome Measures, Study Status, Eligibility, Study Description and Oversight
24 October 19, 2017 Study Status, Contacts/Locations, Study Design and Oversight
25 December 15, 2017 Contacts/Locations and Study Status
26 January 10, 2018 Study Status and Contacts/Locations
27 February 7, 2018 Study Status and Contacts/Locations
28 May 2, 2018 Study Status and Contacts/Locations
29 May 7, 2018 Study Status
30 June 28, 2018 Study Status
31 July 12, 2018 Study Status
32 July 26, 2018 Contacts/Locations and Study Status
33 October 15, 2018 Study Status and Contacts/Locations
34 November 15, 2018 Study Status and Contacts/Locations
35 January 10, 2019 Study Status and Contacts/Locations
36 February 12, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
37 May 16, 2019 Contacts/Locations, Sponsor/Collaborators, Study Status, Study Identification and References
38 July 3, 2019 Study Status, Study Identification, Study Design and Conditions
39 August 20, 2019 Recruitment Status, Contacts/Locations and Study Status
40 September 20, 2019 Contacts/Locations and Study Status
41 October 21, 2019 Study Status and Contacts/Locations
42 October 31, 2019 Contacts/Locations and Study Status
43 December 2, 2019 Contacts/Locations and Study Status
44 February 13, 2020 Contacts/Locations, Conditions and Study Status
45 February 28, 2020 Study Status and Contacts/Locations
46 March 18, 2020 Contacts/Locations and Study Status
47 April 23, 2020 Contacts/Locations and Study Status
48 May 5, 2020 Study Status and Contacts/Locations
49 May 19, 2020 Contacts/Locations and Study Status
50 June 15, 2020 Contacts/Locations and Study Status
51 June 30, 2020 Contacts/Locations and Study Status
52 July 13, 2020 Contacts/Locations and Study Status
53 July 27, 2020 Contacts/Locations and Study Status
54 August 10, 2020 Contacts/Locations and Study Status
55 August 25, 2020 Study Status and Contacts/Locations
56 September 8, 2020 Study Status and Contacts/Locations
Comparison Format:

Scroll up to access the controls

Changes (Side-by-Side) for Study: NCT02598661
June 30, 2020 (v51) -- July 13, 2020 (v52)

Changes in: Contacts/Locations and Study Status

Study Identification
Unique Protocol ID: CR107947 CR107947
Brief Title: Study to Evaluate Imetelstat (GRN163L) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Study to Evaluate Imetelstat (GRN163L) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Official Title: A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
Secondary IDs: 63935937MDS3001 [Geron Corporation]
2015-002874-19 [EudraCT Number]
63935937MDS3001 [Geron Corporation]
2015-002874-19 [EudraCT Number]
Study Status
Record Verification: June 2020 July 2020
Overall Status: Recruiting Recruiting
Study Start: November 24, 2015 November 24, 2015
Primary Completion: August 15, 2022 [Anticipated ] August 15, 2022 [Anticipated ]
Study Completion: May 15, 2023 [Anticipated ] May 15, 2023 [Anticipated ]
First Submitted: October 27, 2015 October 27, 2015
First Submitted that
Met QC Criteria:
November 4, 2015 November 4, 2015
First Posted: November 6, 2015 [Estimate ] November 6, 2015 [Estimate ]
Last Update Submitted that
Met QC Criteria:
June 30, 2020 July 13, 2020
Last Update Posted: July 1, 2020 [Actual ] July 15, 2020 [Actual ]
Sponsor/Collaborators
Sponsor: Geron Corporation Geron Corporation
Responsible Party: Sponsor Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug: Yes Yes
U.S. FDA-regulated Device: No No
Data Monitoring: Yes Yes
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment. The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment.
Detailed Description: This is a Phase 2/3, multicenter study of imetelstat that consists of 2 parts. Part 1 is an open-label, single-arm design to assess the efficacy and safety of imetelstat. Approximately 55 participants will be enrolled in Part 1, including the expansion cohort, and be followed-up for safety, hematologic improvement and reduction in transfusion requirement. Part 2 of the study will be initiated if data from Part 1 are supportive of a satisfactory benefit/risk profile. Part 2 is a double-blind, randomized design to compare the efficacy of imetelstat with placebo. Approximately 170 eligible participants will be randomized in a 2:1 ratio to receive either imetelstat or placebo, respectively. Each part of the study will consist of 3 phases: a Screening phase (up to 28 days); a treatment phase; and a post-treatment follow-up phase which will continue until death, lost to follow-up, withdrawal of consent, or the End of the Study (whichever occurs first). The End of the Study is defined as 2 years after the study entry of the last participant or anytime the sponsor terminates the study, whichever comes first. This is a Phase 2/3, multicenter study of imetelstat that consists of 2 parts. Part 1 is an open-label, single-arm design to assess the efficacy and safety of imetelstat. Approximately 55 participants will be enrolled in Part 1, including the expansion cohort, and be followed-up for safety, hematologic improvement and reduction in transfusion requirement. Part 2 of the study will be initiated if data from Part 1 are supportive of a satisfactory benefit/risk profile. Part 2 is a double-blind, randomized design to compare the efficacy of imetelstat with placebo. Approximately 170 eligible participants will be randomized in a 2:1 ratio to receive either imetelstat or placebo, respectively. Each part of the study will consist of 3 phases: a Screening phase (up to 28 days); a treatment phase; and a post-treatment follow-up phase which will continue until death, lost to follow-up, withdrawal of consent, or the End of the Study (whichever occurs first). The End of the Study is defined as 2 years after the study entry of the last participant or anytime the sponsor terminates the study, whichever comes first.
Conditions
Conditions: Myelodysplastic Syndromes Myelodysplastic Syndromes
Keywords: Myelodysplastic Syndromes
Imetelstat
GRN163L
Relapsed/refractory to ESAs
Transfusion dependent
IMerge
Myelodysplastic Syndromes
Imetelstat
GRN163L
Relapsed/refractory to ESAs
Transfusion dependent
IMerge
Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 2/Phase 3Phase 2/Phase 3
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 33
Masking: Double (Participant, Investigator)Double (Participant, Investigator)
Allocation: RandomizedRandomized
Enrollment: 225 [Anticipated ] 225 [Anticipated ]
Arms and Interventions
Arms Assigned Interventions
Experimental: Part 1: Imetelstat
Imetelstat will be administered at a starting dose of 7.5 milligram per kilogram (mg/kg) given intravenously every 4 weeks, until disease progression, unacceptable toxicity, or withdrawal of consent, or lack of response.
Drug: Imetelstat
Imetelstat will be administered at a starting dose of 7.5 milligram per kilogram (mg/kg) given intravenously every 4 weeks, until disease progression, unacceptable toxicity, or withdrawal of consent, or lack of response.
Experimental: Part 2: Imetelstat
Imetelstat will be administered at a starting dose of 7.5 milligram per kilogram (mg/kg) given intravenously every 4 weeks, until disease progression, unacceptable toxicity, or withdrawal of consent, or lack of response.
Drug: Imetelstat
Imetelstat will be administered at a starting dose of 7.5 milligram per kilogram (mg/kg) given intravenously every 4 weeks, until disease progression, unacceptable toxicity, or withdrawal of consent, or lack of response.
Placebo Comparator: Part 2: Placebo
Matching Placebo to Imetelstat will be administered.
Drug: Placebo
Matching Placebo to Imetelstat will be administered.
Outcome Measures
Primary Outcome Measures:
1. Percentage of participants without any red blood cell (RBC) transfusion during any consecutive 8 week period
During study (approximately 2 years)
Percentage of participants without any red blood cell (RBC) transfusion during any consecutive 8 week period
During study (approximately 2 years)
Secondary Outcome Measures:
2. Number of Participants with Adverse Events (AEs)
During study (approximately 2 years)
Number of Participants with Adverse Events (AEs)
During study (approximately 2 years)
3. Percentage of participants without any red blood cell (RBC) transfusion during any consecutive 24 week period
During study (approximately 2 years)
Percentage of participants without any red blood cell (RBC) transfusion during any consecutive 24 week period
During study (approximately 2 years)
4. Time to the 8-week RBC transfusion independence (TI)
During study (approximately 2 years)
Time to the 8-week RBC transfusion independence (TI)
During study (approximately 2 years)
5. Duration of RBC TI
During study (approximately 2 years)
Duration of RBC TI
During study (approximately 2 years)
6. Percentage of Participants with hematologic improvement
During study (approximately 2 years)
Percentage of Participants with hematologic improvement
During study (approximately 2 years)
7. Percentage of Participants with Complete remission (CR) or Partial remission (PR) as Per International Working Group (IWG) Response Criteria 2006
During study (approximately 2 years)
Percentage of Participants with Complete remission (CR) or Partial remission (PR) as Per International Working Group (IWG) Response Criteria 2006
During study (approximately 2 years)
8. Overall survival
During study (approximately 2 years)
Overall survival
During study (approximately 2 years)
9. Progression Free Survival (PFS)
Progression free survival will be assessed as the time interval from study Day 1 to the first date of disease progression or death from any cause, whichever occurs first. As per IWG criteria disease progression is defined as: at least one of the following: at least 50 percent (%) decrement from maximum response levels in granulocytes or platelets; reduction in hemoglobin by greater than or equal to (>=) 1.5 gram per deciliter (g/dL); transfusion dependence.

[Time Frame: During study (approximately 2 years) ]
Progression Free Survival (PFS)
Progression free survival will be assessed as the time interval from study Day 1 to the first date of disease progression or death from any cause, whichever occurs first. As per IWG criteria disease progression is defined as: at least one of the following: at least 50 percent (%) decrement from maximum response levels in granulocytes or platelets; reduction in hemoglobin by greater than or equal to (>=) 1.5 gram per deciliter (g/dL); transfusion dependence.

[Time Frame: During study (approximately 2 years) ]
10. Time to Progression to Acute Myeloid Leukemia
During study (approximately 2 years)
Time to Progression to Acute Myeloid Leukemia
During study (approximately 2 years)
11. Percentage of Participants with Transfusion
During study (approximately 2 years)
Percentage of Participants with Transfusion
During study (approximately 2 years)
12. Amount of Transfusions
During study (approximately 2 years)
Amount of Transfusions
During study (approximately 2 years)
13. Percentage of Participants receiving any myeloid growth factors
During study (approximately 2 years)
Percentage of Participants receiving any myeloid growth factors
During study (approximately 2 years)
14. Maximum Observed Plasma Concentration (Cmax)
During study (approximately 2 years)
Maximum Observed Plasma Concentration (Cmax)
During study (approximately 2 years)
15. Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t)
During study (approximately 2 years)
Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t)
During study (approximately 2 years)
16. Percentage of Participants with antibodies to imetelstat
During study (approximately 2 years)
Percentage of Participants with antibodies to imetelstat
During study (approximately 2 years)
17. Medical Resource Utilization Data in Part 2
During study (approximately 2 years)
Medical Resource Utilization Data in Part 2
During study (approximately 2 years)
18. Assessment of Functional Assessment of Cancer Therapy- Anemia-Related Effects (FACT-An) in Part 2
The Functional Assessment of Cancer Therapy Anemia (FACT-An), is included in order to provide an assessment of the subject's functional status, well-being, and symptoms over time.

[Time Frame: During study (approximately 2 years) ]
Assessment of Functional Assessment of Cancer Therapy- Anemia-Related Effects (FACT-An) in Part 2
The Functional Assessment of Cancer Therapy Anemia (FACT-An), is included in order to provide an assessment of the subject's functional status, well-being, and symptoms over time.

[Time Frame: During study (approximately 2 years) ]
19. Assessment of EuroQol 5 Dimension Questionnaire (EQ-5D-5L) in Part 2
The EQ-5D-5L is a generic measure of health status. EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

[Time Frame: During study (approximately 2 years) ]
Assessment of EuroQol 5 Dimension Questionnaire (EQ-5D-5L) in Part 2
The EQ-5D-5L is a generic measure of health status. EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

[Time Frame: During study (approximately 2 years) ]
20. Assessment of Quality of Life in Myelodysplasia Scale (QUALMS) in Part 2
The QUALMS is a 38-item measure that assesses health-related quality of life for patients with MDS. Thirty-three items are used to calculate the total score, as well as the 14 item physical burden (QUALMS-P), 3-item benefit-finding (QUALMS-BF), and 11-item emotional burden (QUALMS-E) subscales.

[Time Frame: During study (approximately 2 years) ]
Assessment of Quality of Life in Myelodysplasia Scale (QUALMS) in Part 2
The QUALMS is a 38-item measure that assesses health-related quality of life for patients with MDS. Thirty-three items are used to calculate the total score, as well as the 14 item physical burden (QUALMS-P), 3-item benefit-finding (QUALMS-BF), and 11-item emotional burden (QUALMS-E) subscales.

[Time Frame: During study (approximately 2 years) ]
21. Assessment of Participant Global Impression of Change (PGIC) in Part 2
The Participant Global Impression of Change (PGIC) is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved".

[Time Frame: During study (approximately 2 years) ]
Assessment of Participant Global Impression of Change (PGIC) in Part 2
The Participant Global Impression of Change (PGIC) is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved".

[Time Frame: During study (approximately 2 years) ]
22. Change From Baseline in QTc Interval at Day 1 of Part 2
Change from baseline in QTc interval by Fridericia's correction method (ΔQTcF) will be assessed in part 2.

[Time Frame: Baseline and Day 1 ]
Change From Baseline in QTc Interval at Day 1 of Part 2
Change from baseline in QTc interval by Fridericia's correction method (ΔQTcF) will be assessed in part 2.

[Time Frame: Baseline and Day 1 ]
Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age:
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

Inclusion Criteria:

  • Man or woman greater than or equal to (>=) 18 years of age
  • In Part 1, diagnosis of myelodysplastic syndrome (MDS) according to World Health Organization (WHO) criteria
  • International Prognostic Scoring System (IPSS) low Risk or intermediate-1 risk MDS
  • Red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units transfused over an 8-week period during the 16 weeks prior to Study Entry; pre-transfusion hemoglobin (Hb) should be less than or equal to 9.0 gram per deciliter (g/dL) to count towards the 4 units total
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

Exclusion Criteria:

  • Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients
  • Participant has received an investigational drug or used an invasive investigational medical device within 30 days prior to Study Entry or is currently enrolled in an investigational study
  • Prior treatment with imetelstat
  • Have received corticosteroids greater than (>) 30 milligram per day (mg/day) prednisone or equivalent, or growth factor treatment within 4 weeks prior to study entry
  • a) Prior treatment with a hypomethylating agent (example [eg], azacitidine, decitabine); b) Prior treatment with lenalidomide; c) Has received an erythropoiesis-stimulating agent (ESA) or any chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to study entry (8 weeks for long-acting ESAs)

Inclusion Criteria:

  • Man or woman greater than or equal to (>=) 18 years of age
  • In Part 1, diagnosis of myelodysplastic syndrome (MDS) according to World Health Organization (WHO) criteria
  • International Prognostic Scoring System (IPSS) low Risk or intermediate-1 risk MDS
  • Red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units transfused over an 8-week period during the 16 weeks prior to Study Entry; pre-transfusion hemoglobin (Hb) should be less than or equal to 9.0 gram per deciliter (g/dL) to count towards the 4 units total
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

Exclusion Criteria:

  • Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients
  • Participant has received an investigational drug or used an invasive investigational medical device within 30 days prior to Study Entry or is currently enrolled in an investigational study
  • Prior treatment with imetelstat
  • Have received corticosteroids greater than (>) 30 milligram per day (mg/day) prednisone or equivalent, or growth factor treatment within 4 weeks prior to study entry
  • a) Prior treatment with a hypomethylating agent (example [eg], azacitidine, decitabine); b) Prior treatment with lenalidomide; c) Has received an erythropoiesis-stimulating agent (ESA) or any chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to study entry (8 weeks for long-acting ESAs)
Contacts/Locations
Central Contact: Faye Feller, MD
Email: mds3001-info@Geron.com
Faye Feller, MD
Email: mds3001-info@Geron.com
Central Contact Backup: Souria Dougherty
Email: mds3001-info@Geron.com
Souria Dougherty
Email: mds3001-info@Geron.com
Study Officials: Faye Feller, MD
Study Director
Geron Corporation
Faye Feller, MD
Study Director
Geron Corporation
Locations: United States, AlabamaUnited States, Alabama
UAB Comprehensive Cancer Center
[Active, not recruiting]
Birmingham, Alabama, United States, 35294
UAB Comprehensive Cancer Center
[Active, not recruiting]
Birmingham, Alabama, United States, 35294
United States, CaliforniaUnited States, California
CBCC Global Research, Inc
[Recruiting]
Bakersfield, California, United States, 93309
CBCC Global Research, Inc
[Recruiting]
Bakersfield, California, United States, 93309
UCLA Ronald Regan Medical Center
[Recruiting]
Los Angeles, California, United States, 90095
UCLA Ronald Regan Medical Center
[Recruiting]
Los Angeles, California, United States, 90095
United States, ConnecticutUnited States, Connecticut
Yale University School Of Medicine
[Completed]
New Haven, Connecticut, United States, 06510
Yale University School Of Medicine
[Completed]
New Haven, Connecticut, United States, 06510
United States, IllinoisUnited States, Illinois
University of Chicago
[Completed]
Chicago, Illinois, United States, 60637-1426
University of Chicago
[Completed]
Chicago, Illinois, United States, 60637-1426
United States, IndianaUnited States, Indiana
Franciscan Health
[Completed]
Indianapolis, Indiana, United States, 46237-8601
Franciscan Health
[Completed]
Indianapolis, Indiana, United States, 46237-8601
United States, MarylandUnited States, Maryland
St. Agnes Healthcare, Inc
[Recruiting]
Baltimore, Maryland, United States, 21229-5201
St. Agnes Healthcare, Inc
[Recruiting]
Baltimore, Maryland, United States, 21229-5201
Center for Cancer and Blood Disorders
[Recruiting]
Bethesda, Maryland, United States, 20817
Center for Cancer and Blood Disorders
[Recruiting]
Bethesda, Maryland, United States, 20817
United States, MinnesotaUnited States, Minnesota
Mayo Clinic Rochester
[Completed]
Rochester, Minnesota, United States, 55902
Mayo Clinic Rochester
[Completed]
Rochester, Minnesota, United States, 55902
United States, MissouriUnited States, Missouri
Washington University School of Medicine
[Recruiting]
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
[Recruiting]
Saint Louis, Missouri, United States, 63110
United States, New MexicoUnited States, New Mexico
University of New Mexico Cancer Center
[Recruiting]
Albuquerque, New Mexico, United States, 87131
University of New Mexico Cancer Center
[Recruiting]
Albuquerque, New Mexico, United States, 87131
United States, New YorkUnited States, New York
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
[Recruiting]
New York, New York, United States, 10029
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
[Recruiting]
New York, New York, United States, 10029
Columbia Presbyterian
[Active, not recruiting]
New York, New York, United States, 10032
Columbia Presbyterian
[Active, not recruiting]
New York, New York, United States, 10032
Columbia University Medical Center
[Recruiting]
New York, New York, United States, 10032
United States, OhioUnited States, Ohio
Cleveland Clinic Taussig Cancer
[Recruiting]
Cleveland, Ohio, United States, 44195
Cleveland Clinic Taussig Cancer
[Recruiting]
Cleveland, Ohio, United States, 44195
The Ohio State Comprehensive Cancer Center
[Recruiting]
Columbus, Ohio, United States, 43210
The Ohio State Comprehensive Cancer Center
[Recruiting]
Columbus, Ohio, United States, 43210
United States, South DakotaUnited States, South Dakota
Prairie lakes Healthcare system, Inc
[Recruiting]
Watertown, South Dakota, United States, 57201
Prairie lakes Healthcare system, Inc
[Recruiting]
Watertown, South Dakota, United States, 57201
United States, TennesseeUnited States, Tennessee
Tennessee Oncology at Centennial Medical Center
[Completed]
Nashville, Tennessee, United States, 37203
Tennessee Oncology at Centennial Medical Center
[Completed]
Nashville, Tennessee, United States, 37203
United States, TexasUnited States, Texas
Simmons Comprehensive Cancer Center
[Recruiting]
Dallas, Texas, United States, 75390
Simmons Comprehensive Cancer Center
[Recruiting]
Dallas, Texas, United States, 75390
BelgiumBelgium
ZNA Stuivenberg- Middelheim
[Recruiting]
Antwerpen, Belgium
ZNA Stuivenberg- Middelheim
[Recruiting]
Antwerpen, Belgium
AZ Klina
[Recruiting]
Brasschaat, Belgium, 2930
AZ Klina
[Recruiting]
Brasschaat, Belgium, 2930
Algemeen Ziekenhuis Sint-Jan
[Recruiting]
Brugge, Belgium, 8000
Algemeen Ziekenhuis Sint-Jan
[Recruiting]
Brugge, Belgium, 8000
Universitair Ziekenhuis Gent
[Recruiting]
Gent, Belgium, 9000
Universitair Ziekenhuis Gent
[Recruiting]
Gent, Belgium, 9000
Az Groeninge
[Recruiting]
Kortrijk, Belgium, 8500
Az Groeninge
[Recruiting]
Kortrijk, Belgium, 8500
UZ Leuven - Campus Gasthuisberg
[Recruiting]
Leuven, Belgium, 3000
UZ Leuven - Campus Gasthuisberg
[Recruiting]
Leuven, Belgium, 3000
GZA Ziekenhuizen - Campus Sint
[Recruiting]
Wilrijk, Belgium
GZA Ziekenhuizen - Campus Sint
[Recruiting]
Wilrijk, Belgium
Canada, OntarioCanada, Ontario
The Ottawa Hospital
[Recruiting]
Ottawa, Ontario, Canada, K1G 8L6
The Ottawa Hospital
[Recruiting]
Ottawa, Ontario, Canada, K1G 8L6
Princess Margaret Hospital
[Recruiting]
Toronto, Ontario, Canada, M5G 2L7
Princess Margaret Hospital
[Recruiting]
Toronto, Ontario, Canada, M5G 2L7
CanadaCanada
Sunnybrook Health Sciences Centre
[Recruiting]
Toronto, Canada
Sunnybrook Health Sciences Centre
[Recruiting]
Toronto, Canada
Czechia, Brno-městoCzechia, Brno-město
Fakultni nemocnice Brno
[Recruiting]
Brno, Brno-město, Czechia, 625 00
Fakultni nemocnice Brno
[Recruiting]
Brno, Brno-město, Czechia, 625 00
CzechiaCzechia
FN Hradec Kralove
[Recruiting]
Hradec Králové, Czechia, 50005
FN Hradec Kralove
[Recruiting]
Hradec Králové, Czechia, 50005
FN Kralovske Vinohrady
[Recruiting]
Praha 10, Czechia, 100 34
FN Kralovske Vinohrady
[Recruiting]
Praha 10, Czechia, 100 34
Vseobecna fakultni nemocnice v Praze
[Recruiting]
Praha 2, Czechia, 128 08
Vseobecna fakultni nemocnice v Praze
[Recruiting]
Praha 2, Czechia, 128 08
France, IsèreFrance, Isère
CHU de Grenoble - Hôpital Albe
[Recruiting]
La Tronche, Isère, France, 38700
CHU de Grenoble - Hôpital Albe
[Recruiting]
La Tronche, Isère, France, 38700
France, VienneFrance, Vienne
CHU de Poitiers
[Recruiting]
Poitiers, Vienne, France, 86021
CHU de Poitiers
[Recruiting]
Poitiers, Vienne, France, 86021
FranceFrance
CHU d'Angers
[Recruiting]
Angers, France, 49933
CHU d'Angers
[Recruiting]
Angers, France, 49933
CHRU de Lille - Hopital Claude Huriez - Maladies du Sang
[Recruiting]
Lille, France, 59037
CHRU de Lille - Hopital Claude Huriez - Maladies du Sang
[Recruiting]
Lille, France, 59037
CHU de Limoges, Hopital Dupuytren
[Recruiting]
Limoges, France, 87042
CHU de Limoges, Hopital Dupuytren
[Recruiting]
Limoges, France, 87042
CHU de Nice Hopital de l Archet
[Recruiting]
Nice, France, 06200
CHU de Nice Hopital de l Archet
[Recruiting]
Nice, France, 06200
Hopital Saint-Louis
[Recruiting]
Paris Cedex 10, France, 75475
Hopital Saint-Louis
[Recruiting]
Paris Cedex 10, France, 75475
Institut Universitaire du Cancer Toulouse Oncopole
[Completed]
Toulouse, France, 31059
Institut Universitaire du Cancer Toulouse Oncopole
[Completed]
Toulouse, France, 31059
CHU Bretonneau
[Recruiting]
Tours Cedex, France, 37044
CHU Bretonneau
[Recruiting]
Tours Cedex, France, 37044
Germany, Baden-WürttembergGermany, Baden-Württemberg
University Hospital Freiburg
[Recruiting]
Freiburg, Baden-Württemberg, Germany, 79106
University Hospital Freiburg
[Recruiting]
Freiburg, Baden-Württemberg, Germany, 79106
Germany, SachsenGermany, Sachsen
University Hospital Leipzig
[Recruiting]
Leipzig, Sachsen, Germany, 4107
University Hospital Leipzig
[Recruiting]
Leipzig, Sachsen, Germany, 4107
GermanyGermany
Studienzentrum für Hämatologie, Onkologie,Diabetologie, Endoskopie und Fußambulanz
[Recruiting]
Aschaffenburg, Germany, 63739
Studienzentrum für Hämatologie, Onkologie,Diabetologie, Endoskopie und Fußambulanz
[Recruiting]
Aschaffenburg, Germany, 63739
University Hospital Bonn
[Recruiting]
Bonn, Germany, 53127
University Hospital Bonn
[Recruiting]
Bonn, Germany, 53127
Universitatsklinikum Carl Gustav Carcus Dresden
[Recruiting]
Dresden, Germany, 01307
Universitatsklinikum Carl Gustav Carcus Dresden
[Recruiting]
Dresden, Germany, 01307
Universitätsklinikum Düsseldorf
[Recruiting]
Duesseldorf, Germany, 40225
Universitätsklinikum Düsseldorf
[Recruiting]
Duesseldorf, Germany, 40225
Universitaetsklinikum Koeln
[Completed]
Koeln, Germany, 50937
Universitaetsklinikum Koeln
[Completed]
Koeln, Germany, 50937
Johannes Gutenberg Universität
[Recruiting]
Mainz, Germany, 55131
Johannes Gutenberg Universität
[Recruiting]
Mainz, Germany, 55131
Klinikum rechts der Isar an der Technischen Universität München
[Completed]
München, Germany, 81675
Klinikum rechts der Isar an der Technischen Universität München
[Completed]
München, Germany, 81675
Universitaetsklinikum Ulm
[Completed]
Ulm, Germany, 89081
Universitaetsklinikum Ulm
[Completed]
Ulm, Germany, 89081
Israel, Hagalil SaintIsrael, Hagalil Saint
Kaplan Medical Center
[Recruiting]
Reẖovot, Hagalil Saint, Israel, 7610001
Kaplan Medical Center
[Recruiting]
Reẖovot, Hagalil Saint, Israel, 7610001
Israel, HaMerkazIsrael, HaMerkaz
The Edith Wolfson Medical Center
[Recruiting]
H̱olon, HaMerkaz, Israel, 58100
The Edith Wolfson Medical Center
[Recruiting]
H̱olon, HaMerkaz, Israel, 58100
Meir Medical Center
[Recruiting]
Kfar Saba, HaMerkaz, Israel, 44281
Meir Medical Center
[Recruiting]
Kfar Saba, HaMerkaz, Israel, 44281
Israel, HaZafon
Ha'Emek Medical Center
[Recruiting]
Afula, HaZafon, Israel, 1834111
Israel, Tel-AvivIsrael, Tel-Aviv
The Chaim Sheba Medical Center
[Recruiting]
Tel HaShomer, Tel-Aviv, Israel, 5265601
The Chaim Sheba Medical Center
[Recruiting]
Tel HaShomer, Tel-Aviv, Israel, 5265601
IsraelIsrael
Carmel MC
[Recruiting]
Haifa, Israel, 3436212
Carmel MC
[Recruiting]
Haifa, Israel, 3436212
Rabin Medical Center, Beilinson Hospital
[Recruiting]
Petah Tikva, Israel, 4941492
Rabin Medical Center, Beilinson Hospital
[Recruiting]
Petah Tikva, Israel, 4941492
Italy, Potenza
Irccs Crob
[Recruiting]
Rionero In Vulture, Potenza, Italy, 85028
ItalyItaly
AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi
[Recruiting]
Ancona, Italy, 60020
AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi
[Recruiting]
Ancona, Italy, 60020
Policlinico Sant'Orsola Malpighi
[Recruiting]
Bologna, Italy, 40138
Policlinico Sant'Orsola Malpighi
[Recruiting]
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria Careggi di Firenze
[Recruiting]
Firenze, Italy, 50134
Azienda Ospedaliera Universitaria Careggi di Firenze
[Recruiting]
Firenze, Italy, 50134
A.O. Ospedale Niguarda Ca' Granda
[Completed]
Milano, Italy, 20162
A.O. Ospedale Niguarda Ca' Granda
[Completed]
Milano, Italy, 20162
IRCCS Policlinico San Matteo
[Completed]
Pavia, Italy, 27100
IRCCS Policlinico San Matteo
[Completed]
Pavia, Italy, 27100
A.O. Ospedali Riuniti Marche Nord Presidio Ospedaliero S. Salvatore di Pesaro-Stabilim. di Muraglia
[Completed]
Pesaro, Italy, 61122
A.O. Ospedali Riuniti Marche Nord Presidio Ospedaliero S. Salvatore di Pesaro-Stabilim. di Muraglia
[Completed]
Pesaro, Italy, 61122
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
[Recruiting]
Reggio Calabria, Italy, 89124
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
[Recruiting]
Reggio Calabria, Italy, 89124
Fondazione Policlinico Tor Vergata
[Completed]
Roma, Italy, 00133
A.O. Universitaria Policlinico Tor Vergata
[Recruiting]
Roma, Italy, 00133
AO S. Andrea, Università degli Studi di Roma La Sapienza
[Recruiting]
Roma, Italy, 189
AO S. Andrea, Università degli Studi di Roma La Sapienza
[Recruiting]
Roma, Italy, 189
Ospedale di Circolo, PO Varese
[Recruiting]
Varese, Italy, 21100
Ospedale di Circolo, PO Varese
[Recruiting]
Varese, Italy, 21100
Korea, Republic ofKorea, Republic of
Seoul National University Hospital
[Recruiting]
Seoul, Korea, Republic of, 03080
Seoul National University Hospital
[Recruiting]
Seoul, Korea, Republic of, 03080
Asan Medical Center
[Recruiting]
Seoul, Korea, Republic of, 05505
Asan Medical Center
[Recruiting]
Seoul, Korea, Republic of, 05505
Samsung Medical Center
[Recruiting]
Seoul, Korea, Republic of, 06351
Samsung Medical Center
[Recruiting]
Seoul, Korea, Republic of, 06351
The Catholic University of Korea Seoul St. Mary's Hospital
[Recruiting]
Seoul, Korea, Republic of, 06591
The Catholic University of Korea Seoul St. Mary's Hospital
[Recruiting]
Seoul, Korea, Republic of, 06591
Severance Hospital, Yonsei Uni
[Recruiting]
Seoul, Korea, Republic of, 3722
Severance Hospital, Yonsei Uni
[Recruiting]
Seoul, Korea, Republic of, 3722
NetherlandsNetherlands
Meander Medisch Centrum
[Recruiting]
Amersfoort, Netherlands, 3813 TZ
Meander Medisch Centrum
[Recruiting]
Amersfoort, Netherlands, 3813 TZ
VU Medisch Centrum
[Recruiting]
Amsterdam, Netherlands, 1081 HV
VU Medisch Centrum
[Recruiting]
Amsterdam, Netherlands, 1081 HV
Universitair Medisch Centrum Groningen
[Active, not recruiting]
Groningen, Netherlands, 9713 GZ
Universitair Medisch Centrum Groningen
[Active, not recruiting]
Groningen, Netherlands, 9713 GZ
Radboud Umcn
[Recruiting]
Nijmegen, Netherlands, 6525 GA
Radboud Umcn
[Recruiting]
Nijmegen, Netherlands, 6525 GA
Russian FederationRussian Federation
Emergency Hospital of Dzerzhinsk
[Recruiting]
Dzerzhinsk, Russian Federation, 606019
Emergency Hospital of Dzerzhinsk
[Recruiting]
Dzerzhinsk, Russian Federation, 606019
City Clinical Hospital
[Recruiting]
Moscow, Russian Federation, 129301
City Clinical Hospital
[Recruiting]
Moscow, Russian Federation, 129301
Nizhniy Novgorod Region Clinical Hospital
[Recruiting]
Nizhny Novgorod, Russian Federation, 603126
Nizhniy Novgorod Region Clinical Hospital
[Recruiting]
Nizhny Novgorod, Russian Federation, 603126
Ryazan Regional Clinical Hospital
[Active, not recruiting]
Ryazan, Russian Federation, 390039
Ryazan Regional Clinical Hospital
[Active, not recruiting]
Ryazan, Russian Federation, 390039
FGU-Russian Research Institut
[Recruiting]
Saint Petersburg, Russian Federation, 191024
FGU-Russian Research Institut
[Recruiting]
Saint Petersburg, Russian Federation, 191024
Oncologic Dispensary No.2
[Recruiting]
Sochi, Russian Federation, 354057
Oncologic Dispensary No.2
[Recruiting]
Sochi, Russian Federation, 354057
Spain, CádizSpain, Cádiz
H.U.Pta.del Mar
[Recruiting]
Cadiz, Cádiz, Spain, 11009
H.U.Pta.del Mar
[Recruiting]
Cadiz, Cádiz, Spain, 11009
SpainSpain
Hosp. Univ. Germans Trias I Pujol
[Recruiting]
Badalona, Spain, 08916
Hosp. Univ. Germans Trias I Pujol
[Recruiting]
Badalona, Spain, 08916
Hosp. Univ. Vall D Hebron
[Recruiting]
Barcelona, Spain, 08035
Hosp. Univ. Vall D Hebron
[Recruiting]
Barcelona, Spain, 08035
Hosp. Clinic I Provincial de Barcelona
[Completed]
Barcelona, Spain, 08036
Hosp. Clinic I Provincial de Barcelona
[Completed]
Barcelona, Spain, 08036
Hosp. Gral. Univ. Gregorio Maranon
[Recruiting]
Madrid, Spain, 28007
Hosp. Gral. Univ. Gregorio Maranon
[Recruiting]
Madrid, Spain, 28007
Hosp. Univ. La Paz
[Recruiting]
Madrid, Spain, 28046
Hosp. Univ. La Paz
[Recruiting]
Madrid, Spain, 28046
Hosp. Clinico Univ. de Salamanca
[Recruiting]
Salamanca, Spain, 37007
Hosp. Clinico Univ. de Salamanca
[Recruiting]
Salamanca, Spain, 37007
Hospital Universitario Nuestra Señora de Valme
[Recruiting]
Sevilla, Spain, 41014
Hospital Universitario Nuestra Señora de Valme
[Recruiting]
Sevilla, Spain, 41014
Hospital Universitario Doctor
[Recruiting]
Valencia, Spain, 46017
Hospital Universitario Doctor
[Recruiting]
Valencia, Spain, 46017
Hospital Universitari i Politecnic La Fe
[Recruiting]
Valencia, Spain, 46026
Hospital Universitari i Politecnic La Fe
[Recruiting]
Valencia, Spain, 46026
United Kingdom, NottinghamshireUnited Kingdom, Nottinghamshire
Nottingham University Hospitals NHS Trust
[Recruiting]
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Nottingham University Hospitals NHS Trust
[Recruiting]
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
United KingdomUnited Kingdom
Aberdeen Royal Infirmary
[Recruiting]
Aberdeen, United Kingdom
Aberdeen Royal Infirmary
[Recruiting]
Aberdeen, United Kingdom
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services