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BMT CTN Core - Dana-Farber Cancer Institute and MGH Consortium

Award Number: UG1HL069249
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2001
PERIOD OF PERFORMANCE END DATE: 06/30/2031

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BMT CTN Core - Dana-Farber Cancer Institute and MGH Consortium - Project Summary The promise of marrow transplantation (HCT) has been hampered by the threat of relapse, opportunistic infection (OI) and graft-versus host disease (GVHD). These three complications interlock in a Gordian knot that have traditionally precluded independent resolution strategies. In theory, better targeted GVHD prevention would reduce the need for additional immunosuppression (IS) post-HCT, and subsequently lower the rates of OI, as well as of relapse, by conserving the graft-versus tumor (GVT) effect. Transformative advances in the realm of GVHD prevention have been possible due to creative immunomodulatory approaches targeting T-lymphocytes, such as early in-vivo T-cell modulation (post-transplant cyclophosphamide or PTCy based strategies) and co- stimulation blockade of the T-cell and antigen-presenting cell (APC) interaction (Abatacept/Aba). In addition, with a deeper understanding of the role of humoral immunity in chronic GVHD (cGVHD), we and others have shown that B-cell blockade using monoclonal antibodies can be very effective in the prevention and treatment of cGVHD. Hence, we are entering an era in transplantation where we have in a sense, an embarrassment of riches of potential therapeutics, but have yet to establish which of these could be the most effective GVHD prevention strategy, to cut the proverbial Gordian knot, and result in the best patient outcomes. In this project, we focus on the most effective strategy to prevent acute and cGVHD, while maintaining the GVT effect, with acceptable rates of OI. First, we expand on our prior work which has shown that co-stimulation blockade of the CD28/CTLA-4 interaction with Aba (CTLA-4 Ig) results in T-cell inhibition and reduction in aGVHD lethality, first shown in murine and non-human primate models, and then established in early phase and randomized clinical trials. We propose to incorporate Aba with standard of care (SOC) tacrolimus (Tac) and methotrexate (MTX) peri-transplant for reduction of aGVHD. Further, recognizing that does not prevent cGVHD, we seek to develop a cGVHD prevention strategy adjunctive to Aba, leveraging our insights from basic murine and human studies indicating that germinal center formation, the development of autologous and allogeneic antibodies, and B cell cytokines are all important in the generation of cGVHD, This will further expand on our work over the last decade, showing that CD20 targeted monoclonal antibodies (rituximab, Obinutuzumab/Obin) can effectively prevent moderate/severe cGVHD, when given in the first year post-HCT. We propose a 2 arm, phase II randomized trial comparing the combination of Aba/Tac/MTX/Obin (ATOM) with PTCy/Tac/mycophenolate in the myeloablative (MAC) unrelated donor setting (URD) using peripheral blood stem cells (PBSC), to establish the most effective transplant platform to optimize GVHD and non-GVHD outcomes. The intermediate goal is to compare the ability of each therapy to achieve the best GVHD free relapse free survival outcome after 2 years. The long-term goal is to allow us to pick-the-winner for a definitive larger phase III randomized controlled trial to establish the SOC in MAC URD PBSC HCT.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $257,014 )
2025	2025	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Blood Diseases and Resources Research	001	25	7/23/2025	NON-COMPETING CONTINUATION	$257,014
2025	2023	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Blood Diseases and Resources Research	000	23	2/17/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $257,014

Issue Date FY: 2024 ( Subtotal = $267,000 )
2024	2024	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Blood Diseases and Resources Research	001	24	8/13/2024	COMPETING CONTINUATION	$267,000
2024	2023	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Blood Diseases and Resources Research	000	23	7/29/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $267,000

Issue Date FY: 2023 ( Subtotal = $203,233 )
2023	2023	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	Blood Diseases and Resources Research	000	23	6/29/2023	NON-COMPETING CONTINUATION	$203,233
														Subtotal = $203,233

Issue Date FY: 2022 ( Subtotal = $203,233 )
2022	2022	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	Blood Diseases and Resources Research	000	22	7/1/2022	NON-COMPETING CONTINUATION	$203,233
														Subtotal = $203,233

Issue Date FY: 2021 ( Subtotal = $203,233 )
2021	2021	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	Blood Diseases and Resources Research	000	21	6/15/2021	NON-COMPETING CONTINUATION	$203,233
														Subtotal = $203,233

Issue Date FY: 2020 ( Subtotal = $203,233 )
2020	2020	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	Blood Diseases and Resources Research	000	20	6/5/2020	NON-COMPETING CONTINUATION	$203,233
														Subtotal = $203,233

Issue Date FY: 2019 ( Subtotal = $203,233 )
2019	2019	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	Blood Diseases and Resources Research	000	19	5/23/2019	NON-COMPETING CONTINUATION	$203,233
														Subtotal = $203,233

Issue Date FY: 2018 ( Subtotal = $193,072 )
2018	2018	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	Blood Diseases and Resources Research	000	18	6/8/2018	NON-COMPETING CONTINUATION	$193,072
														Subtotal = $193,072

Issue Date FY: 2017 ( Subtotal = $193,072 )
2017	2017	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	Blood Diseases and Resources Research	002	17	9/12/2017	COMPETING CONTINUATION	$3,041
2017	2017	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	Blood Diseases and Resources Research	000	17	7/26/2017	COMPETING CONTINUATION	$190,031
2017	2017	DANA-FARBER CANCER INSTITUTE, INC.	450 BROOKLINE AVE	BOSTON	MA	02115	SUFFOLK	USA	Blood Diseases and Resources Research	001	17	8/22/2017	COMPETING CONTINUATION	$0
														Subtotal = $193,072

Grand Total All Awards = $1,926,323

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BMT CTN Core - Dana-Farber Cancer Institute and MGH Consortium

Award Number: UG1HL069249

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2001

PERIOD OF PERFORMANCE END DATE: 06/30/2031

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