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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)

Comparing Graft-versus-Host Disease (GVHD) Prophylaxis Regimens for Survival Outcomes

Recruiting
18 years and older
All

This study investigates two different methods for preventing graft-versus-host disease (GVHD) in patients who have undergone a transplant. GVHD is a condition where the transplanted cells attack the recipient's body. The study aims to see which method better supports survival without GVHD or cancer relapse over one year.

Participants will undergo specific procedures to monitor their health and the effectiveness of the GVHD prevention methods. These procedures help ensure that the investigational approaches are safe and effective for patients.

  • Who can participate: Adults with a left ventricular ejection fraction of at least 45% can participate. Women must use two effective birth control methods or abstain from heterosexual intercourse, while men must use barrier contraception or abstain.
  • Study details: Participants will receive one of two GVHD prevention treatments. A placebo is not involved in this study.
  • Study Timelines: The study will last 1 year.
Study details
    Myelodysplasia
    Diffuse Large B Cell Lymphoma
    Chronic Myelogenous Leukemia
    Hodgkin Lymphoma
    Chronic Lymphocytic Leukemia
    Small Lymphocytic Lymphoma
    Acute Leukemia
    Follicular Lymphoma
    Mantle Cell Lymphoma

TX10537

19 February 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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