Abstract
The need for prospective randomized clinical trials investigating novel graft-versus-host disease (GVHD) prevention strategies that 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-transplantation cyclophosphamide with tacrolimus/methotrexate (Tac/MTX) for GVHD prevention demonstrated no significant differences in the primary endpoint of chronic GVHD relapse-free survival among the 3 approaches. The trial did not demonstrate a superior approach compared with Tac/MTX; however, it did highlight 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 the results of BMT CTN 1301 and their implications for clinical practice and future clinical trial design.
Original language | English (US) |
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Pages (from-to) | 419-425 |
Number of pages | 7 |
Journal | Transplantation and Cellular Therapy |
Volume | 28 |
Issue number | 8 |
DOIs |
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State | Published - Aug 2022 |
Keywords
- Allogeneic hematopoietic cell transplantation
- CD34 selection
- Graft-versus-host disease
- Post-transplantation cyclophosphamide
ASJC Scopus subject areas
- Immunology and Allergy
- Molecular Medicine
- Hematology
- Cell Biology
- Transplantation