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NCT02345850 · ClinicalTrials.gov registry record · Phase 3
Calcineurin Inhibitor-Free Interventions BMT CTN 1301 for Prevention of Graft-versus-Host Disease (BMT CTN 1301)
A Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 3
- Development phase
- 346
- Enrollment target
NCT02345850: Completed Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT02345850 is a Phase 3 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 346 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02345850, a Phase 3 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 346 participants
- Enrollment target
Study Summary
The study is designed as a three arm randomized Phase III, multicenter trial comparing two calcineurin inhibitor (CNI)-free strategies for Graft-versus-Host Disease (GVHD) prophylaxis to standard tacrolimus and methotrexate (Tac/Mtx) in patients with hematologic malignancies undergoing myeloablative conditioning hematopoietic stem cell transplantation.
Primary Outcome
The primary endpoint of the trial is Chronic GVHD/Relapse-Free Survival (CRFS), treated as a time to event variable. An event for this time to event outcome is defined as moderate to severe chronic GVHD, disease relapse, or death by any cause. Participant will be censored if lost to follow up prior to 2 years. Time is from randomization to the event of moderate to severe chronic GVHD, disease relapse, death, last follow up, or 2 years, whichever comes first. The primary analysis is performed usi
Interventions
- DRUG Cyclophosphamide
- DRUG Tacrolimus
- PROCEDURE Unmanipulated Bone Marrow Graft with Tacrolimus/Methotrexate
- PROCEDURE Mobilized CD34-selected Peripheral Blood Stem Cell graft
- PROCEDURE Unmanipulated Bone Marrow Graft with Cyclophosphamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 346 participants |
| Start Date | 2015-08 |
| Est. Completion | 2020-10-05 |
| Phase | Phase 3 |
What the finished NCT02345850 record still lists
NCT02345850 is an interventional study that assigns participants to a tested intervention. The registered 346 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02345850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02345850 about?
NCT02345850 is a clinical study titled "Calcineurin Inhibitor-Free Interventions BMT CTN 1301 for Prevention of Graft-versus-Host Disease (BMT CTN 1301)". The study is designed as a three arm randomized Phase III, multicenter trial comparing two calcineurin inhibitor (CNI)-free strategies for Graft-versus-Host Disease (GVHD) prophylaxis to standard tacrolimus and methotrexate (Tac/Mtx) in patients with hematologic malignancies undergoing myeloablative...
What is the current status of trial NCT02345850?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 346 participants. The study started on 2015-08. Estimated completion is 2020-10-05.
What interventions are being tested in trial NCT02345850?
The interventions under investigation include: Cyclophosphamide (DRUG), Tacrolimus (DRUG), Unmanipulated Bone Marrow Graft with Tacrolimus/Methotrexate (PROCEDURE), Mobilized CD34-selected Peripheral Blood Stem Cell graft (PROCEDURE), Unmanipulated Bone Marrow Graft with Cyclophosphamide (PROCEDURE).
Who is sponsoring clinical trial NCT02345850?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02345850's enrollment target sits among peer trials
346 1049th of 2000 higher than 951 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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