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NCT06615050 · ClinicalTrials.gov registry record · Phase 3
A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)
A Phase 3 study of Graft-versus-host Disease (GVHD), sponsored by Incyte Corporation.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 572
- Enrollment target
- 20
- Study locations
NCT06615050: Recruiting Phase 3 study of Graft-versus-host Disease (GVHD), sponsored by Incyte Corporation.
NCT06615050 is a Phase 3 study of Graft-versus-host Disease (GVHD) that is actively recruiting participants, run by Incyte Corporation. The registered enrollment target is 572 participants, above the 205-participant average among 3 other Graft-versus-host Disease (GVHD) trials with a reported enrollment target (179% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06615050, a Phase 3 study of Graft-versus-host Disease (GVHD), is actively recruiting participants, sponsored by Incyte Corporation.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 572 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
Primary Outcome
GFS will be defined as the elapsed time between the date of transplant to Grade III-IV acute graft-versus host disease (GVHD), chronic GVHD requiring systemic immune suppression, or death by any cause.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Methotrexate (MTX)
- DRUG Tacrolimus (Tac)
- DRUG Ruxolitinib (Rux)
- DRUG Mycophenolate mofetil (MMF)
Study Locations (20)
Michigan
- University of Michigan - Ann Arbor
- Karmanos Cancer Institute - Detroit
- Henry Ford Hospital - Detroit
North Carolina
- University of North Carolina At Chapel Hill - Chapel Hill
- Levine Cancer Institute - Charlotte
- Duke University Medical Center - Durham
California
- Stanford Cancer Center - Palo Alto
- University of California San Francisco - San Francisco
Florida
- University of Miami - Miami
- Moffitt Cancer Center - Tampa
New York
- Mount Sinai Hospital - New York
- Memorial Sloan Kettering - New York
Ohio
- Cleveland Clinic - Cleveland
- Ohio State University - Columbus
Georgia
- Blood and Marrow Transplant Group of Georgia - Atlanta
Indiana
- Indiana University Cancer Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 572 participants |
| Start Date | 2025-04-02 |
| Est. Completion | 2031-01-17 |
| Phase | Phase 3 |
What NCT06615050 shows while recruiting
NCT06615050 is an interventional study that assigns participants to a tested intervention. The registered 572 participants enrollment target is mid-sized for trials with a published cap, above the 205-participant average among 3 other Graft-versus-host Disease (GVHD) trials with a reported enrollment target (179% higher).
The record links to 1 condition, with Graft-versus-host Disease (GVHD) appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT06615050 names 20 study sites across 12 states, led by Michigan, North Carolina, California.
Frequently Asked Questions
What is clinical trial NCT06615050 about?
NCT06615050 is a clinical study titled "A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)". The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
What is the current status of trial NCT06615050?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 572 participants. The study started on 2025-04-02. Estimated completion is 2031-01-17.
What conditions does trial NCT06615050 study?
This clinical trial studies the following conditions: Graft-versus-host Disease (GVHD).
What interventions are being tested in trial NCT06615050?
The interventions under investigation include: Cyclophosphamide (DRUG), Methotrexate (MTX) (DRUG), Tacrolimus (Tac) (DRUG), Ruxolitinib (Rux) (DRUG), Mycophenolate mofetil (MMF) (DRUG).
Who is sponsoring clinical trial NCT06615050?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06615050 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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