drugset
drugset / Trial / NCT03314974

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

NCT03314974 ↗

Phase 2 Recruiting 300 enrolled Masonic Cancer Center, University of Minnesota
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine/busulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).

Timeline

Start
2018-03-30
Primary completion
2027-06-10
Completion
2028-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule — —
Subject Fludaribine Unknown — —
Background Cyclophosphamide Other / unclassified — —
Background Mycophenolate Mofetil Small molecule — —
Background Tacrolimus Small molecule — —

Indications

Burkitt lymphoma T-cell and NK-cell neoplasm acute biphenotypic leukemia anemia bone marrow failure syndrome chronic lymphocytic leukemia/small lymphocytic lymphoma chronic myeloid leukemia diffuse large B-cell lymphoma follicular lymphoma juvenile myelomonocytic leukemia lymphoblastic lymphoma lymphoplasmacytic lymphoma mantle cell lymphoma marginal zone lymphoma myelodysplastic syndrome myelofibrosis plasma cell leukemia plasma cell myeloma prolymphocytic leukemia