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

Wael Saber, Jennifer Le Rademacher, Mikkael Sekeres, Brent Logan, Moira Lewis, Adam Mendizabal, Eric Leifer, Frederick R. Appelbaum, Mary M. Horowitz, Ryotaro Nakamura, Corey S. Cutler

Research output: Contribution to journalArticle

11 Scopus citations

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 3years. 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.

Original languageEnglish (US)
Pages (from-to)1566-1572
Number of pages7
JournalBiology of Blood and Marrow Transplantation
Volume20
Issue number10
DOIs
StatePublished - Oct 1 2014

Keywords

  • Biologic assignment
  • MDS
  • Transplantation

ASJC Scopus subject areas

  • Hematology
  • Transplantation

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