Building a Fit for Purpose Clinical Trials Infrastructure to Accelerate the Assessment of Novel Hematopoietic Cell Transplantation Strategies and Cellular Immunotherapies.

Abstract

Article Tools REVIEW ARTICLES Immunotherapy for Hematologic Malignancies Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.20.01623 Journal of Clinical Oncology - published online before print January 12, 2021 PMID: 33434065 Building a Fit for Purpose Clinical Trials Infrastructure to Accelerate the Assessment of Novel Hematopoietic Cell Transplantation Strategies and Cellular Immunotherapies Steven M. Devine , MD1,2xSteven M. DevineSearch for articles by this author; and Mary M. Horowitz , MD, MS3,4xMary M. HorowitzSearch for articles by this author Show More 1National Marrow Donor Program/Be The Match, Minneapolis, MN2Center for International Blood and Marrow Transplant Research, Minneapolis, MN3Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, WI4Division of Hematology-Oncology, Department of Medicine, Medical College of Wisconsin, WI https://doi.org/10.1200/JCO.20.01623 First Page Full Text PDF Figures and Tables © 2021 by American Society of Clinical OncologyCONTEXTKey ObjectiveThis review describes the development and evolution of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), a National Institutes of Health–funded clinical trials infrastructure dedicated to accelerating the assessment of innovative hematopoietic cell transplantation (HCT) strategies and cellular Immunotherapies (CITs).Knowledge GeneratedOver its 19-year history, the BMT CTN has adapted in response to its successes and failures. It has engaged an increasingly broad and diverse group of stakeholders within the HCT and CIT fields.RelevanceWe outline several themes key to the success of the BMT CTN that can be applied to other successful publicly or philanthropically funded clinical trials enterprises dedicated to studying immunotherapies.SUPPORTSupported by Grant No. U24HL138660 from the National Heart, Lung, and Blood Institute and the National Cancer Institute; Grants No. U24CA076518 and U24CA233032 from the National Cancer Institute; and Contracts No. HHSH250201700006C and HHSH250201700007C with the Health Resources and Services Administration.AUTHOR CONTRIBUTIONSConception and design: All authorsCollection and assembly of data: All authorsData analysis and interpretation: All authorsManuscript writing: All authorsFinal approval of manuscript: All authorsAccountable for all aspects of the work: All authorsAUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTERESTBuilding a Fit for Purpose Clinical Trials Infrastructure to Accelerate the Assessment of Novel Hematopoietic Cell Transplantation Strategies and Cellular ImmunotherapiesThe following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).Steven M. DevineHonoraria: KiadisConsulting or Advisory Role: Bristol Myers SquibbResearch Funding: Orca Bio (Inst), Kiadis (Inst)Travel, Accommodations, Expenses: Orca BioMary M. HorowitzConsulting or Advisory Role: Magenta (Inst), Janssen Research & Development (Inst), Medac (Inst)Research Funding: Biovitrum (Inst), Jazz Pharmaceuticals (Inst), Magenta (Inst), Novartis (Inst), Kite/Gilead (Inst), Actinium Pharmaceuticals Inst), Amgen (Inst), Amneal (Inst), Anthem (Inst), Bluebird Bio (Inst), Bristol Myers Squibb (Inst), Chimerix (Inst), CSL Behring (Inst), Cyto-Sen Therapeutics (Inst), Daiichi Sankyo (Inst), Gamida Cell (Inst), GlaxoSmithKline (Inst), Mesoblast (Inst), Miltenyi Biotec (Inst), Neovii Biotech (Inst), Oncoimmune (Inst), Pfizer (Inst), Pharmacyclics (Inst), Regeneron (Inst), Sanofi (Inst), Seattle Genetics (Inst), Shire (Inst)No other potential conflicts of interest were reported.