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Multicenter biologic assignment trial comparing reduced-intensity allogeneic hematopoietic cell transplant to hypomethylating therapy or best supportive care in patients aged 50 to 75 with intermediate-2 and high-risk myelodysplastic syndrome: Blood and Marrow Transplant Clinical Trials Network #1102 study rationale, design, and methods. Biol Blood Marrow Transplant 2014 Oct;20(10):1566-72 PMID: 24972249 PMCID: PMC4169902

Pubmed ID

24972249

Abstract

The introduction of reduced-intensity conditioning (RIC) regimens made it possible to offer allogeneic hematopoietic cell transplantation (alloHCT) to older patients with myelodysplastic syndromes (MDS). However, the relative risks and benefits of alloHCT compared with novel nontransplant therapies continue to be the source of considerable uncertainty. We will perform a prospective biologic assignment trial to compare RIC alloHCT with nontransplant therapies based on donor availability. Primary outcome is 3-year overall survival. Secondary outcomes include leukemia-free survival, quality of life, and cost-effectiveness. Four hundred patients will be enrolled over roughly 3 years. Planned subgroup analyses will evaluate key biologic questions, such as the impact of age and response to hypomethylating agents on treatment effects. Findings from this study potentially may set a new standard of care for older MDS patients who are considered candidates for alloHCT.

Author List

Saber W, Le Rademacher J, Sekeres M, Logan B, Lewis M, Mendizabal A, Leifer E, Appelbaum FR, Horowitz MM, Nakamura R, Cutler CS

Authors

Mary M. Horowitz MD, MS Center Director, Professor in the Medicine department at Medical College of Wisconsin
Brent R. Logan PhD Director, Professor in the Institute for Health and Equity department at Medical College of Wisconsin
Wael Saber MD, MS Associate Professor in the Medicine department at Medical College of Wisconsin




Scopus

2-s2.0-84912532203   10 Citations

MESH terms used to index this publication - Major topics in bold

Age Factors
Aged
Antimetabolites, Antineoplastic
Cost-Benefit Analysis
DNA Methylation
Female
Hematopoietic Stem Cell Transplantation
Histocompatibility Testing
Humans
Intention to Treat Analysis
Male
Middle Aged
Myeloablative Agonists
Myelodysplastic Syndromes
Prognosis
Prospective Studies
Quality of Life
Risk Factors
Survival Analysis
Transplantation Conditioning
Transplantation, Homologous
Unrelated Donors
jenkins-FCD Prod-299 9ef562391eceb2b8f95265c767fbba1ce5a52fd6