A Phase III Study Comparing Two Medication Regimens to Prevent Graft-versus-Host Disease after Stem Cell Transplantation, plus a Companion Study of the Microbiome

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Full Title

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 (PROGRESS III)/Companion Study: Microbiome and Immune Reconstitution in Cellular Therapies and Hematopoietic Stem Cell Transplantation (Mi-Immune) (NMDP IRB)

Purpose

A bone marrow transplant (sometimes called “allogeneic stem cell transplant”) is one way of treating blood and lymph node cancers. One potential complication of stem cell transplantation is graft-versus-host disease (GVHD). GVHD is caused when cells from the donor view the recipient’s cells as foreign, resulting in symptoms such as rash, diarrhea, nausea, and vomiting, among others.

The purpose of this study is to compare two combinations of drugs to prevent GVHD. Patients will be randomly assigned to receive either tacrolimus/methotrexate or tacrolimus/mycophenolate mofetil/cyclophosphamide. Doctors want to know if one combination is better than the other or if they are equally effective.

In another part of the study, researchers are seeking to understand if bacteria and proteins in the gut and body fluids (“the microbiome”) can help predict how well a patient does after a transplant. The investigators will collect blood, urine, and stool samples as well as a detailed health history regarding patients’ infections and antibiotic use.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have acute leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, myelodysplasia, or lymphoma and be planning to receive a stem cell transplant from a donor with a reduced-intensity treatment regimen.
  • Patients must have a matched related or unrelated peripheral blood stem cell donor.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Brian Shaffer at 212-639-2212.

Protocol

19-192

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators