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NCI Pediatric In Vivo Testing Program - Leukemia

Award Number: U01CA199000
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2015
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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NCI Pediatric In Vivo Testing Program - Leukemia - Project Summary/Abstract This application seeks renewal of funding for a Research Program for acute lymphoblastic leukemia (ALL) in vivo testing as part of the NCI Pediatric In Vivo Testing Program (Ped-In Vivo-TP). Recent US Government legislation, combined with the relative rarity and higher cure rates of childhood cancer compared with adults, emphasize the importance of new agent preclinical testing programs aimed at maximizing the likelihood that only the most active drugs will be advanced into early phase clinical trials. The broad aim of this application is to improve the treatment options for children with aggressive and/or drug resistant ALL by prioritizing new drugs for clinical trials in the disease using state-of-the-art preclinical experimental models. This aim will be accomplished using a large panel of 90 pediatric ALL patient-derived xenografts (PDXs) that have undergone a high level of cell and molecular characterization and authentication. The PDXs to be used in this study were all established as models of orthotopic disease in immune- deficient (NOD/SCID or NSG) mice from direct patient explants without prior ex vivo culture. The PDXs develop as systemic disease in NSG mice and infiltrate the same major organs in mice as the primary disease in human patients. Engraftment and responses to treatment are monitored by measuring the proportion of human leukemia cells in the peripheral blood of mice on a weekly basis, which provides a reliable representation of overall leukemia burden in the animals. Where luciferase-expressing PDXs are available, this testing will be augmented by bioluminescence imaging of animals. The broad methodology will involve inoculation of PDX cells into NSG mice, a lag time to allow the disease to establish, followed by drug treatment and monitoring to assess drug responses. Methods of response evaluation have been developed using stringent criteria modeled after the clinical setting, in order to minimize the likelihood of over-predicting drug responses in mice leading to failure of drugs in the clinic. The proposed drug testing will adopt multiple formats, including conventional drug testing (6- 10 mice/group), single-mouse trial testing (1 PDX x 1 mouse x 1 drug) and testing of new agents in combination with standard-of-care drugs. In this fashion, this Research Program aims to test 8-10 new agents per year. By completing the major objectives outlined in this proposal, the long term health benefit aims to improve the treatment options and quality of life for children with aggressive forms of ALL who would otherwise succumb to their disease.


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 = $454,977 )
2025	2025	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON				AUS	Cancer Treatment Research	001	10	6/27/2025	NON-COMPETING CONTINUATION	$454,977
2025	2024	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON				AUS	Cancer Treatment Research	000	9	3/31/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $454,977

Issue Date FY: 2024 ( Subtotal = $454,977 )
2024	2024	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON				AUS	Cancer Treatment Research	001	9	6/28/2024	NON-COMPETING CONTINUATION	$454,977
2024	2023	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON				AUS	Cancer Treatment Research	000	8	12/19/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $454,977

Issue Date FY: 2023 ( Subtotal = $454,977 )
2023	2023	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON				AUS	Cancer Treatment Research	000	8	7/4/2023	NON-COMPETING CONTINUATION	$445,877
2023	2023	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON				AUS	Cancer Treatment Research	001	8	9/13/2023	NON-COMPETING CONTINUATION	$9,100
														Subtotal = $454,977

Issue Date FY: 2022 ( Subtotal = $445,877 )
2022	2022	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON				AUS	Cancer Treatment Research	003	7	8/11/2022	NON-COMPETING CONTINUATION	$445,877
2022	2021	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW			AUS	Cancer Treatment Research	002	6	12/8/2021	COMPETING CONTINUATION	$0
2022	2021	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON				AUS	Cancer Treatment Research	000	6	10/28/2021	COMPETING CONTINUATION	$20,091
2022	2021	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON				AUS	Cancer Treatment Research	001	5	10/28/2021	SUPPLEMENT FOR EXPANSION	-$20,091
														Subtotal = $445,877

Issue Date FY: 2021 ( Subtotal = $647,285 )
2021	2021	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW			AUS	Cancer Treatment Research	001	5	2/3/2021	SUPPLEMENT FOR EXPANSION	$192,309
2021	2021	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW			AUS	Cancer Treatment Research	005	6	8/17/2021	COMPETING CONTINUATION	$454,976
2021	2021	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW			AUS	Cancer Treatment Research	006	5	8/17/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2019	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW			AUS	Cancer Treatment Research	004	5	8/17/2021	NON-COMPETING CONTINUATION	$0
2021	2019	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW			AUS	Cancer Treatment Research	000	5	2/3/2021	NON-COMPETING CONTINUATION	$0
2021	2018	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW			AUS	Cancer Treatment Research	003	4	7/28/2021	NON-COMPETING CONTINUATION	$0
2021	2017	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW			AUS	Cancer Treatment Research	002	3	7/27/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $647,285

Issue Date FY: 2020 ( Subtotal = $193,793 )
2020	2020	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW	2052		AUS	Cancer Treatment Research	001	5	3/17/2020	SUPPLEMENT FOR EXPANSION	$193,793
2020	2019	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW	2052		AUS	Cancer Treatment Research	000	5	3/17/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $193,793

Issue Date FY: 2019 ( Subtotal = $387,584 )
2019	2019	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW	2052		AUS	Cancer Treatment Research	000	5	9/19/2019	NON-COMPETING CONTINUATION	$387,584
														Subtotal = $387,584

Issue Date FY: 2018 ( Subtotal = $394,802 )
2018	2018	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW	2052		AUS	Cancer Treatment Research	000	4	6/29/2018	NON-COMPETING CONTINUATION	$394,802
														Subtotal = $394,802

Issue Date FY: 2017 ( Subtotal = $390,171 )
2017	2017	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW	2052		AUS	Cancer Treatment Research	000	3	6/21/2017	NON-COMPETING CONTINUATION	$390,171
														Subtotal = $390,171

Issue Date FY: 2016 ( Subtotal = $385,674 )
2016	2016	UNIVERSITY OF NEW SOUTH WALES	14 BARKER STREET 2052	SYDNEY				AUS	Cancer Treatment Research	001	2	6/9/2016	NON-COMPETING CONTINUATION	$385,674
2016	2015	UNIVERSITY OF NEW SOUTH WALES	14 BARKER STREET 2052	SYDNEY				AUS	Cancer Treatment Research	000	1	1/12/2016	NEW	$0
														Subtotal = $385,674

Issue Date FY: 2015 ( Subtotal = $391,002 )
2015	2015	UNIVERSITY OF NEW SOUTH WALES	14 BARKER STREET 2052	SYDNEY				AUS	Cancer Treatment Research	000	1	7/30/2015	NEW	$391,002
														Subtotal = $391,002

Grand Total All Awards = $4,601,119

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NCI Pediatric In Vivo Testing Program - Leukemia

Award Number: U01CA199000

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 08/01/2015

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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