GVHD prophylaxis in Peripheral Blood Stem Cell Transplantation - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out whether one medication (Tacrolimus/methotrexate) is better than another medication(Tacrolimus/mycophenolate mofetil/cyclophosphamide) in preventing graft-versus-host disease (GVHD).

What is the Condition Being Studied?

Graft versus- host disease (GVHD)

Who Can Participate in the Study?

Adults that are undergoing allogeneic PBSC transplant for the treatment of acute leukemia and chronic myelogenous leukemia.

Age Group

What is Involved?

If you choose to be in the study you will be asked to go through a medical screening that includes a physical, a heart test (EKG and Echo) a breathing test, and potentially a bone marrow biopsy.

If still eligible you will be asked to:
-Take the study medication as directed
-Blood draws
-Continue treatment as you would with any transplant

Study Details

Full Title
BMT CTN 1703: A Randomized, Multi-Center, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation Companion Study: BMT CTN 1801: Microbiome and Immune Reconstitution in Cellular Therapies and Hematopoietic Stem Cell Transplantation (Mi-Immune)
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB: PRO00102430
NCT: NCT03959241
Phase III
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center