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Recruiting Phase 3 NCT06615050

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)

Trial Parameters

Condition Graft-versus-host Disease (GVHD)
Sponsor Incyte Corporation
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 572
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-04-02
Completion 2031-01-17
Interventions
Tacrolimus (Tac)Methotrexate (MTX)Ruxolitinib (Rux)

Brief 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

Eligibility Criteria

Inclusion Criteria: * Age 18.0 years or older at the time of enrollment. * Participants undergoing allogeneic HCT for one of the following indications: * Acute leukemia or chronic myelogenous leukemia with no circulating blasts and with less than 5% blasts in the bone marrow. Therapy related myeloid neoplasms are allowed. * Myelodysplasia/chronic myelomonocytic leukemia with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \< 5% versus 5-10% blasts in this disease). Therapy related myeloid neoplasms are allowed. * Lymphoma \[follicular lymphoma, Hodgkin lymphoma, diffuse large B cell lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma and anaplastic large cell lymphoma\]. * Planned NMA/reduced intensity conditioning regimen. * Participants must have a related or unrelated PBSC donor as follows: * Sibling donor must be a 6/6 match for HLA-A

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