@article{f52cce82368641feb4ea254ccfc5b7d6,
title = "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",
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.",
keywords = "Biologic assignment, MDS, Transplantation",
author = "Wael Saber and {Le Rademacher}, Jennifer and Mikkael Sekeres and Brent Logan and Moira Lewis and Adam Mendizabal and Eric Leifer and Appelbaum, {Frederick R.} and Horowitz, {Mary M.} and Ryotaro Nakamura and Cutler, {Corey S.}",
note = "Funding Information: Financial disclosure: The design and conduct of the BMT CTN 1102 is supported by Grant/Cooperative Agreement U10 HL069294 from the National Heart, Lung, and Blood Institute and the National Cancer Institute (NCI) of the National Institutes of Health . Data collection on alloHCT recipients will be through the CIBMTR, which is supported by Public Health Service Grant/Cooperative Agreement U24 CA076518 from the NCI , the NHLBI , and the National Institute of Allergy and Infectious Diseases ; contract HHSH250201200016 C with the Health Resources and Services Administration of the US Department of Health and Human Services; grants N00014-12-1-0142 and N00014-13-1-0039 from the Office of Naval Research ; and grants from Allos Therapeutics, Inc. ; Amgen, Inc. ; Anonymous donation to the Medical College of Wisconsin ; Ariad Pharmaceuticals ; Be The Match Foundation ; Blue Cross and Blue Shield Association ; Celgene ; Fresenius-Biotech North America, Inc. ; Gamida Cell Teva Joint Venture Ltd. ; Genentech, Inc. ; Gentium SpA ; Genzyme Corporation ; GlaxoSmithKline ; HistoGenetics, Inc. ; Kiadis Pharma ; The Leukemia & Lymphoma Society ; The Medical College of Wisconsin ; Merck & Co., Inc. ; Millennium: The Takeda Oncology Co. ; Milliman USA, Inc. ; Miltenyi Biotec, Inc. ; National Marrow Donor Program ; Onyx Pharmaceuticals ; Optum Healthcare Solutions, Inc. ; Osiris Therapeutics, Inc. ; Otsuka America Pharmaceutical, Inc. ; Remedy Informatics ; Sanofi US ; Seattle Genetics ; Sigma-Tau Pharmaceuticals ; Soligenix, Inc. ; StemCyte, A Global Cord Blood Therapeutics Co. ; Stemsoft Software, Inc. ; Swedish Orphan Biovitrum ; Tarix Pharmaceuticals ; Terumo BCT ; Teva Neuroscience, Inc. ; Texas Instruments Inc. ; and WellPoint , Inc. . The views expressed in this article do not reflect the official policy or position of the National Institutes of Health, the Department of the Navy, the Department of Defense, or any other agency of the US Government. Publisher Copyright: {\textcopyright} 2014 American Society for Blood and Marrow Transplantation.",
year = "2014",
month = oct,
day = "1",
doi = "10.1016/j.bbmt.2014.06.010",
language = "English (US)",
volume = "20",
pages = "1566--1572",
journal = "Biology of Blood and Marrow Transplantation",
issn = "1083-8791",
publisher = "Elsevier Inc.",
number = "10",
}