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NCT02208037 · ClinicalTrials.gov registry record · Phase 2
Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls (BMT CTN 1203)
A Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 279
- Enrollment target
- 20
- Study locations
NCT02208037: Completed Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT02208037 is a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 279 participants, above the 180-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02208037, a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 279 participants
- Enrollment target
- 20
- Study locations
Study Summary
Acute Graft-versus-Host-Disease (GVHD) is an important cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to determine if any of three new GVHD prophylaxis approaches improves the rate of GVHD and relapse free survival at one year after transplant compared to the current standard prophylaxis regimen.
Primary Outcome
GRFS is defined as being free of grade III-IV acute GVHD onset, chronic GVHD onset requiring systemic immunosuppressive therapy, disease relapse or progression, and death from any cause.
Conditions Studied
Interventions
- DRUG Maraviroc
- DRUG Tacrolimus (ARM with Methotrexate)
- DRUG Tacrolimus (ARM with MMF and Cyclophosphamide)
- DRUG Methotrexate (ARM with Maraviroc)
- DRUG Methotrexate (ARM with Bortezomib)
Study Locations (20)
California
- City of Hope National Medical Center - Duarte
- Stanford Hospital and Clinics - Stanford
Florida
- University of Florida College of Medicine (Shands) - Gainesville
- H. Lee Moffitt Cancer Center - Tampa
Georgia
- Emory University - Atlanta
- BMT Program at Northside Hospital - Atlanta
Massachusetts
- Dana Farber Cancer Institute/Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute/Brigham & Women's - Boston
Minnesota
- University of Minnesota - Minneapolis
- Mayo Clinic - Rochester - Rochester
New York
- Roswell Park Cancer Institute - Buffalo
- Memorial Sloan-Kettering Cancer Center - Manhattan
Illinois
- Loyola University Medical Center - Maywood
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2014-08 |
| Est. Completion | 2017-10 |
| Phase | Phase 2 |
What the finished NCT02208037 record still lists
NCT02208037 is an interventional study that assigns participants to a tested intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, above the 180-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (55% higher).
The record links to 9 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Maraviroc is the first listed.
NCT02208037 names 20 study sites across 14 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02208037 about?
NCT02208037 is a clinical study titled "Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls (BMT CTN 1203)". Acute Graft-versus-Host-Disease (GVHD) is an important cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to determine if any of three new GVHD prophylaxis approaches improves the rate of GVHD and relapse free survival at one year after ...
What is the current status of trial NCT02208037?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 279 participants. The study started on 2014-08. Estimated completion is 2017-10.
What conditions does trial NCT02208037 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Acute Leukemia, Lymphoma, B-Cell, Chronic Myelogenous Leukemia.
What interventions are being tested in trial NCT02208037?
The interventions under investigation include: Maraviroc (DRUG), Tacrolimus (ARM with Methotrexate) (DRUG), Tacrolimus (ARM with MMF and Cyclophosphamide) (DRUG), Methotrexate (ARM with Maraviroc) (DRUG), Methotrexate (ARM with Bortezomib) (DRUG).
Who is sponsoring clinical trial NCT02208037?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02208037 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02208037's enrollment target sits among peer trials
279 31st of 187 higher than 156 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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