BMT CTN 1703/1801: 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)

Recruiting
18 years - 100 years
All
1 Location

Brief description of study

The primary objective of the trial is to compare 1 year GVHD-free, relapse-free survival (GRFS) between the two GVHD prophylaxis regimens.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Myelodysplasia,Diffuse Large B Cell Lymphoma,Chronic Myelogenous Leukemia,Hodgkin Lymphoma,Chronic Lymphocytic Leukemia,Small Lymphocytic Lymphoma,Acute Leukemia,Follicular Lymphoma,Mantle Cell Lymphoma
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria

In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Cardiac function: Left ventricular ejection fraction at least 45%.
  • Female patients (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two (2) effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 12 months post-transplant (see Section 2.6.4 for definition of postmenopausal).
  • Male patients (even if surgically sterilized), of partners of women of childbearing potential must agree to one of the following: practice effective barrier contraception (see Section 2.6.4 for list of barrier methods), or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant.

For a full list of participation criteria, please visit clinicaltrials.gov.

 

Updated on 04 Aug 2024. Study ID: 1903006145 (BMTCTN1703/1801)

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