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Are We Making PROGRESS in Preventing Graft-versus-Host Disease and Improving Clinical Outcomes? Impact of BMT CTN 1301 Study Results on Clinical Practice

  1. Author:
    Hamilton, Betty K
    Cutler, Corey
    Divine, Clint
    Juckett, Mark
    LeMaistre, Charles
    Stewart, Susan
    Wilder, Jennifer
    Horowitz, Mary
    Khera, Nandita
    Burns, Linda J

  2. Author Address

    Department of Hematology and Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH. Electronic address: hamiltb2@ccf.org., Division of Stem Cell Transplantation and Cellular Therapy, Dana Farber Cancer Institute, Boston, MA., Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, KS., Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN., Sarah Cannon, Nashville, TN., Blood and Marrow Transplant Information Network, Highland Park, IL., Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research sponsored by the National Cancer Institute, Frederick, MD., Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI., Division of Hematology and Oncology, Mayo Clinic Arizona, Phoenix, AZ., Center for International Blood and Marrow Transplant Research, Milwaukee, WI.,
    1. Year: 2022
    2. Date: May 09
    3. Epub Date: 2022 05 09
  2. Journal: Transplantation and Cellular Therapy
  4. Type of Article: Article
  1. Abstract:

    The need for prospective randomized clinical trials investigating novel graft-versus-host disease (GVHD) prevention strategies which include other clinical outcomes impacted by GVHD has been highlighted as a priority for the field of hematopoietic cell transplantation. A recently completed study through the Blood and Marrow Transplant Clinical Trials Network (BMT CTN 1301) comparing CD34+ selection and post-transplant cyclophosphamide to tacrolimus/methotrexate (Tac/MTX) for GVHD prevention demonstrated no significant differences in the primary endpoint of Chronic GVHD-Relapse-Free Survival (CRFS) among the three approaches. The trial did not demonstrate a superior approach compared to Tac/MTX; however, it highlights several challenges in determining the best and most relevant approaches to clinical trial design, particularly in the context of current and ongoing changes in real world practices. Here, we review BMT CTN 1301 results and implications for clinical practice and future clinical trial design. Copyright © 2022. Published by Elsevier Inc.

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External Sources

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  2. DOI: 10.1016/j.jtct.2022.05.002
  3. PMID: 35550441
  4. PII : S2666-6367(22)01269-6

Library Notes

  1. Fiscal Year: FY2021-2022
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