BMT CTN 1703/1801: Ph3 Randomized of Tac/Mtx vs. PTCy in GVHD prophylaxis in RIC PBSC transplant

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 this Study?

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

Age Group
Adults
Participating Institutions

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

Contacts
Hematological Malignancies, Cellular Therapy and ABMT
Protocol Number
IRB:
PRO00102430

NCT:
NCT03959241
ClinicalTrials.gov
View on ClinicalTrials.gov