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)
NCT06615050 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572
Last updated 2026-05-20
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
Conditions
- Graft-versus-host Disease (GVHD)
Interventions
- DRUG
-
Tacrolimus (Tac)
Tablet or intravenously (IV)
- DRUG
-
Methotrexate (MTX)
Intravenously (IV)
- DRUG
-
Ruxolitinib (Rux)
Tablet
- DRUG
-
Intravenously (IV)
- DRUG
-
Mycophenolate mofetil (MMF)
Tablet or intravenously (IV)
Sponsors & Collaborators
-
Blood and Marrow Transplant Clinical Trials Network
collaborator NETWORK -
National Institutes of Health (NIH)
collaborator NIH -
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
National Cancer Institute (NCI)
collaborator NIH - lead INDUSTRY
Principal Investigators
-
Incyte Medical Monitor · Incyte Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-02
- Primary Completion
- 2031-01-17
- Completion
- 2031-01-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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