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

Purpose

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.

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.

Eligibility

  • Ages: 18 and older
  • Sexes: All
  • Accepts healthy volunteers?: No

For additional eligibility criteria, please contact the study team.

Procedures

Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Methotrexate
Drug: Tacrolimus
Drug: Methotrexate

Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide
Drug: Mycophenolate Mofetil
Drug: Cyclophosphamide

Contact the study team

Additional eligibility criteria and study procedure details can be explained by the study team. Please call or email:

Kristy Applegate
Email: kapplegate@emmes.com
Phone: 301.251.1161

Age

18 to 65
65 and over

Gender

Male
Female

Keywords

Myelodysplasia, Acute Leukemia, Chronic Myelogenous Leukemia (CML), Lymphoma

Principal Investigator

Mary Horowitz, MD, MS

Department

Oncology

Contact Information

kapplegate@emmes.com

301.251.1161


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