BMT CTN 2020 PROGRESS REPORT >100 presented >50 abstracts trials launched >12,000 patients accrued >400,000 biospecimens >100 manuscripts published Progress May 2019 – Report April 2020 www.bmtctn.net Center for International Blood and Marrow Transplant Research 9200 W. Wisconsin Avenue, Suite C5500, Milwaukee, WI 53226 USA Phone: (414) 805-0700 Fax: (414) 805-0714 The Emmes Company, LLC 401 N. Washington Street, Suite 700, Rockville, MD 20850 USA Phone: (301) 251-1161 Fax: (301) 251-1355 National Marrow Donor Program/Be The Match 500 N. 5th Street, Minneapolis, MN 55401 USA Phone: (763) 406-5800 Fax: (763) 406-4370 This is a publication of the Blood and Marrow Transplant Clinical Trials Network Data and Coordinating Center © 2020 All Rights Reserved BMT CTN Progress Report 2020 Table of Contents Table of Contents 1.0 Value the BMT CTN Brings to the Cellular Therapy Community .................................................................... 1 1.1 Areas of Study ...................................................................................................................................................... 2 1.2 Accrual Success .................................................................................................................................................... 4 1.3 Dissemination of Results ..................................................................................................................................... 4 1.3.1 Publications .................................................................................................................................................. 4 1.3.2 Presentations ................................................................................................................................................ 5 1.4 Significant Findings and Impact .......................................................................................................................... 5 1.5 Biorepository and Clinical Trial Data Resources ............................................................................................... 20 1.6 Funding Leverage .............................................................................................................................................. 20 1.7 Key Collaborations ............................................................................................................................................. 20 2.0 Organizational Overview............................................................................................................................ 21 2.1 Data and Coordinating Center .......................................................................................................................... 21 2.2 Clinical Centers .................................................................................................................................................. 21 2.2.1 Core Centers ............................................................................................................................................... 21 2.2.2 Affiliate Centers .......................................................................................................................................... 22 2.3 Committee Structure ......................................................................................................................................... 22 2.3.1 Biomarkers Committee .............................................................................................................................. 25 2.3.2 Clinical Research Associates Committee ................................................................................................... 25 2.3.3 Special Populations Committee ................................................................................................................. 25 2.3.4 Publications, Abstracts, and Presentations Committee ........................................................................... 25 2.3.5 BMT CTN Myeloma Intergroup .................................................................................................................. 25 2.3.6 Scientific Advisory Committees ................................................................................................................. 25 2.3.7 Evidence into Practice Task Force .............................................................................................................. 26 2.3.8 Consent Translations Task Force ............................................................................................................... 26 2.3.9 COVID-19 Funding Task Force .................................................................................................................... 27 3.0 Administrative Functions of the DCC .......................................................................................................... 28 3.1 DCC Partner Organizations ................................................................................................................................ 28 3.2 Specimen Repository Support .......................................................................................................................... 31 3.2.1 Specimen Collection ................................................................................................................................... 31 3.2.2 Research Sample Repository and Central Processing Lab ........................................................................ 33 3.2.3 Maximizing Sample Collection, Quality, and Availability .......................................................................... 33 3.3 Ancillary and Correlative Study Management ................................................................................................. 34 3.3.1 Ancillary and Correlative Studies in Progress ............................................................................................ 34 3.3.2 Completed Ancillary and Correlative Studies ............................................................................................ 42 3.3.3 Completed Correlative Studies Incorporated into Primary Trial Reports ................................................ 50 4.0 Protocol Descriptions ................................................................................................................................. 51 4.1 Protocols Open to Accrual ................................................................................................................................ 51 BMT CTN 1201 / Alliance A051301 ..................................................................................................................... 52 BMT CTN 1502 ..................................................................................................................................................... 54 i BMT CTN Progress Report 2020 Table of Contents BMT CTN 1503 ..................................................................................................................................................... 57 BMT CTN 1507 ..................................................................................................................................................... 60 BMT CTN 1601 / ECOG-ACRIN EA4151 ............................................................................................................... 62 BMT CTN 1702 ..................................................................................................................................................... 64 BMT CTN 1703 / 1801 ......................................................................................................................................... 67 BMT CTN 1704 ..................................................................................................................................................... 70 BMT CTN 1705 ..................................................................................................................................................... 72 BMT CTN 1706 / SWOG S1803 ............................................................................................................................ 74 BMT CTN 1802 ..................................................................................................................................................... 76 BMT CTN 1905 / ITN077AI .................................................................................................................................. 79 4.2 Protocols that Completed Accrual this Reporting Period ................................................................................ 81 BMT CTN 1506 ..................................................................................................................................................... 82 4.3 Protocols that Completed Accrual during a Previous Reporting Period ......................................................... 84 BMT CTN 0101 ..................................................................................................................................................... 87 BMT CTN 0102 ..................................................................................................................................................... 88 BMT CTN 0201 ..................................................................................................................................................... 89 BMT CTN 0202 ....................................................................................................................................................