Trial ID or NCT#

NCT03959241

Status

not recruiting iconNOT RECRUITING

Purpose

1703: The study is designed as a randomized, phase III, multicenter trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: tacrolimus/methotrexate (Tac/MTX) versus post-transplant cyclophosphamide/tacrolimus/mycophenolate mofetil (PTCy/Tac/MMF) in the setting of reduced intensity conditioning (RIC) allogeneic peripheral blood stem cell (PBSC) transplantation. 1801: The goal of this protocol is to test the primary hypothesis that the engraftment stool microbiome diversity predicts one-year non-relapse mortality in patients undergoing reduced intensity allogeneic HCT.

Official Title

A Randomized, Multicenter, 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 (BMT CTN 1703; Progress III); Companion Study: Microbiome and Immune Reconstitution in Cellular Therapies and Hematopoietic Stem Cell Transplantation (BMT CTN 1801; Mi-Immune)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Andrew Rezvani, M.D.
Andrew Rezvani, M.D.
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Ami Bhatt
Ami Bhatt
Associate Professor of Medicine (Hematology) and of Genetics

Contact us to find out if this trial is right for you.

CONTACT

Lindsay Danley
(650) 736-0304