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Blood and Marrow Transplant Clinical Trials Network (BMT CTN) - Core Clinical Centers - UG1

Award Number: UG1HL108987
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: 08/08/2011
PERIOD OF PERFORMANCE END DATE: 06/30/2031

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Blood and Marrow Transplant Clinical Trials Network (BMT CTN) - Core Clinical Centers - UG1 - Project Summary: The goal of the Blood and Marrow Transplant Clinical Trial Network (BMT CTN) is to generate efficacy and safety data from multicenter Phase II and III trials, and advance the science and technology of immune and hematopoietic cellular therapies for the cure of blood disorders. The Moffitt Consortium brings scientific leadership, expertise in research conduct, and robust clinical volumes to support the mission of the BMT CTN. We also submit a project to specifically address major knowledge gaps in the domain of CAR-T therapy, namely the optimal lymphodepleting chemotherapy approach. We propose a national randomized phase II trial to identify an alternative lymphodepleting chemotherapy (LD-chemo) approach that optimizes efficacy and safety in the setting of CD19 CAR-T therapy for large B cell lymphoma (utilizing two approved, commercially available products, axicabtagene ciloleucel (axi-cel) and lisocabtagene maraleucel (liso-cel). The study arms include 1) fludarabine/cyclophosphamide (Flu/Cy) with fludarabine dosing optimized using mathematical modeling of fludarabine exposure, 2) Bendamustine (Benda), and 3) Cladribine/Cy (Clad/Cy). Each of these approaches has been studied in single center series and have evidence in support of improved outcomes. Our proposed trial will for the first time prospectively test these regimens to determine which outperforms traditional Flu/Cy for efficacy (12 month progression-free survival) and toxicity (composite severe toxicity endpoint inclusive of grade 3 or higher cytokine release syndrome (CRS) and immune cell therapy associated neurologic toxicity (ICANS), day 30 severe cytopenias, and severe infection). In parallel, we will interrogate the biologic differences in immune cells and homeostatic cytokines in each study arm and correlate these findings with clinical outcomes. This highly innovative trial has major potential to determine which of these LD-chemo approaches optimizes outcomes, and will inform selection of an approach to be tested in a subsequent randomized phase III trial against conventional standard of care Flu/Cy. The findings will have major impact on clinical practice, the current state of the science, and potential to directly improve patient outcomes.


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 = $214,179 )
2025	2025	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	002	15	7/29/2025	NON-COMPETING CONTINUATION	$214,179
2025	2024	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	001	14	4/2/2025	COMPETING CONTINUATION	$112,888
2025	2023	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	000	13	4/2/2025	NON-COMPETING CONTINUATION	-$112,888
														Subtotal = $214,179

Issue Date FY: 2024 ( Subtotal = $214,179 )
2024	2024	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	000	14	8/13/2024	COMPETING CONTINUATION	$214,179
														Subtotal = $214,179

Issue Date FY: 2023 ( Subtotal = $206,400 )
2023	2023	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	000	13	6/29/2023	NON-COMPETING CONTINUATION	$206,400
														Subtotal = $206,400

Issue Date FY: 2022 ( Subtotal = $206,400 )
2022	2022	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	000	12	7/1/2022	NON-COMPETING CONTINUATION	$206,400
														Subtotal = $206,400

Issue Date FY: 2021 ( Subtotal = $206,400 )
2021	2021	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	000	11	6/22/2021	NON-COMPETING CONTINUATION	$206,400
														Subtotal = $206,400

Issue Date FY: 2020 ( Subtotal = $206,400 )
2020	2020	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	000	10	6/9/2020	NON-COMPETING CONTINUATION	$206,400
														Subtotal = $206,400

Issue Date FY: 2019 ( Subtotal = $206,400 )
2019	2019	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	000	9	5/26/2019	NON-COMPETING CONTINUATION	$206,400
														Subtotal = $206,400

Issue Date FY: 2018 ( Subtotal = $204,042 )
2018	2018	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	001	8	6/8/2018	NON-COMPETING CONTINUATION	$196,080
2018	2017	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	000	7	1/4/2018	COMPETING CONTINUATION	$7,962
														Subtotal = $204,042

Issue Date FY: 2017 ( Subtotal = $194,404 )
2017	2017	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	000	7	7/26/2017	COMPETING CONTINUATION	$194,404
2017	2017	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Blood Diseases and Resources Research	001	7	8/22/2017	COMPETING CONTINUATION	$0
														Subtotal = $194,404

Grand Total All Awards = $1,858,804

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Blood and Marrow Transplant Clinical Trials Network (BMT CTN) - Core Clinical Centers - UG1

Award Number: UG1HL108987

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: 08/08/2011

PERIOD OF PERFORMANCE END DATE: 06/30/2031

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