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Circulating biomarkers of ALK+ anaplastic large cell lymphoma

Award Number: R01CA255350
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 10/01/2022
PERIOD OF PERFORMANCE END DATE: 07/31/2025

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Circulating biomarkers of ALK+ anaplastic large cell lymphoma - Project Summary Anaplastic lymphoma kinase (ALK) is a receptor tyrosine kinase encoded by the ALK gene located on 5q35. Structural alterations including translocations, copy number gains and activating mutations targeting ALK occur in many types of human cancer, including lung cancer, non- Hodgkin lymphomas, Spitzoid melanocytic lesions, neuroblastoma and inflammatory myofibroblastic tumor. In over 80% of pediatric anaplastic large cell lymphoma (ALCL), the most common form of mature T cell lymphoma in this population, the chromosomal aberration t(2;5)(p23;q35) results in the expression of the constitutively active tyrosine kinase NPM-ALK. NPM-ALK positive lymphoma has served as a model for understanding ALK-mediated oncogenesis and development of targeted therapies, thus NPM-ALK related studies carry profound implications for the cancer field in general. Unfortunately, even with current intensive combined chemotherapy, approximately 30% of patients experiences disease progression or recurrence within two years of treatment. However, clinical or genetic factors that cause ALCL relapse are not known. Furthermore, prognostic biomarkers that can be easily obtained using non-invasive methods have not been clearly defined in patients receiving targeted therapies in ALCL. Our central hypothesis is that sensitive and specific quantitative assessment of circulating NPM-ALK transcript using digital droplet (dd)PCR in conjunction with plasma levels of ALK auto- antibody will serve as unique disease-specific biomarkers that will provide an opportunity for assessment of response to therapy and lead to prognostic biomarkers that may identify patients with high risk for relapse. Using plasma samples from uniformly treated patients enrolled in a Children's Oncology Group (COG) Phase II study of Brentuximab Vedotin and Crizotinib with newly diagnosed ALCL, we address our hypothesis through the following specific aims: 1) Determine the utility of ddPCR for minimal disease detection and disease monitoring in ALK+ ALCL, 2) Determine the prognostic utility of anti-ALK immune response in ALK+ ALCL 3) Investigate the prognostic significance of a multivariate model combining ddPCR and immune response to ALK in patients with ALK+ ALCL. The development of sensitive and precise assessment of minimal disseminated disease and/or minimal residual disease will play an important role in management of patients with ALK+ ALCL and facilitate decisions about discontinuation of treatment and identifying patients at risk of relapse/progression.


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: 2026 ( Subtotal = $0 )
2026	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	5	12/9/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Detection and Diagnosis Research	001	2	1/10/2025	NON-COMPETING CONTINUATION	-$1
2025	2022	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	002	3	1/10/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$175,609
2025	2021	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Detection and Diagnosis Research	000	1	1/10/2025	NEW	-$175,608
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $288,649 )
2024	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	5	7/30/2024	NON-COMPETING CONTINUATION	$288,649
														Subtotal = $288,649

Issue Date FY: 2023 ( Subtotal = $361,579 )
2023	2023	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	003	4	7/31/2023	NON-COMPETING CONTINUATION	$297,632
2023	2022	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	002	3	1/19/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$63,947
2023	2022	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	001	3	11/23/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$324,210
2023	2022	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Detection and Diagnosis Research	000	2	11/22/2022	NON-COMPETING CONTINUATION	-$324,210
														Subtotal = $361,579

Issue Date FY: 2022 ( Subtotal = $324,211 )
2022	2022	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Detection and Diagnosis Research	000	2	8/9/2022	NON-COMPETING CONTINUATION	$324,211
														Subtotal = $324,211

Issue Date FY: 2021 ( Subtotal = $363,872 )
2021	2021	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Detection and Diagnosis Research	000	1	8/16/2021	NEW	$363,872
2021	2021	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Detection and Diagnosis Research	001	1	8/18/2021	NEW	$0
														Subtotal = $363,872

Grand Total All Awards = $1,338,311

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Circulating biomarkers of ALK+ anaplastic large cell lymphoma

Award Number: R01CA255350

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 10/01/2022

PERIOD OF PERFORMANCE END DATE: 07/31/2025

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