Language
English
Publication Date
2-1-2022
Journal
Journal of Clinical Oncology
DOI
10.1200/JCO.21.02293
PMID
34855460
PMCID
PMC8797487
PubMedCentral® Posted Date
12-2-2021
PubMedCentral® Full Text Version
Post-print
Abstract
PURPOSE: Calcineurin inhibitors (CNI) are standard components of graft-versus-host disease (GVHD) prophylaxis after hematopoietic cell transplantation (HCT). Prior data suggested that CNI-free approaches using donor T-cell depletion, either by ex vivo CD34 selection or in vivo post-transplant cyclophosphamide (PTCy) as a single agent, are associated with lower rates of chronic GVHD (cGVHD).
METHODS: This multicenter phase III trial randomly assigned patients with acute leukemia or myelodysplasia and an HLA-matched donor to receive CD34-selected peripheral blood stem cell, PTCy after a bone marrow (BM) graft, or tacrolimus and methotrexate after BM graft (control). The primary end point was cGVHD (moderate or severe) or relapse-free survival (CRFS).
RESULTS: Among 346 patients enrolled, 327 received HCT, 300 per protocol. Intent-to-treat rates of 2-year CRFS were 50.6% for CD34 selection (hazard ratio [HR] compared with control, 0.80; 95% CI, 0.56 to 1.15;
CONCLUSION: CNI-free interventions as performed herein did not result in superior CRFS compared with tacrolimus and methotrexate with BM. Lower rates of moderate and severe cGVHD did not translate into improved survival.
Keywords
Adolescent, Adult, Aged, Calcineurin Inhibitors, Chronic Disease, Cyclophosphamide, Disease-Free Survival, Drug Therapy, Combination, Female, Germany, Graft vs Host Disease, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Humans, Immunosuppressive Agents, Male, Methotrexate, Middle Aged, Myeloablative Agonists, Recurrence, Tacrolimus, Time Factors, Transplantation Conditioning, United States, Young Adult
Published Open-Access
yes
Recommended Citation
Luznik, Leo; Pasquini, Marcelo C; Logan, Brent; et al., "Randomized Phase III BMT CTN Trial of Calcineurin Inhibitor-Free Chronic Graft-Versus-Host Disease Interventions in Myeloablative Hematopoietic Cell Transplantation for Hematologic Malignancies" (2022). Faculty and Staff Publications. 800.
https://digitalcommons.library.tmc.edu/baylor_docs/800
Included in
Biochemistry, Biophysics, and Structural Biology Commons, Hematology Commons, Hemic and Lymphatic Diseases Commons, Medical Sciences Commons, Neoplasms Commons, Oncology Commons