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TARGETED THERAPIES FOR CHILDHOOD ACUTE LYMPHOBLASTIC LEUKEMIA

Award Number: RC2CA148529
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2009
PERIOD OF PERFORMANCE END DATE: 12/31/2012

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TARGETED THERAPIES FOR CHILDHOOD ACUTE LYMPHOBLASTIC LEUKEMIA - DESCRIPTION (provided by applicant): Acute lymphoblastic leukemia (ALL) is the most common childhood cancer and is a leading cause of cancer-related death. Although the outcome of children and adolescents with ALL has improved substantially in recent decades, up to 20% of patients will relapse. Among children with a bone marrow (BM) relapse within 36 months of diagnosis, 90% will die. Major advances in understanding the heterogeneity of biologic diseases that comprise ALL have contributed to modern risk stratification algorithms that emphasize the critical contributions of ALL genotype and early response to induction chemotherapy to assign post-induction therapies of different intensities. However, these algorithms are population-based and many children who fail current therapies have features that are indistinguishable at diagnosis from those are cured. Furthermore, except for the 3-4% of children with Philadelphia chromosome positive (Ph+) ALL, current treatments do not include molecularly targeted therapy. Collaborative genomics-based initiatives within the Children's Oncology Group (COG) have revealed previously unrecognized mutations and pathway alterations in childhood ALL that can serve as potential therapeutic targets. The childhood high risk (HR) ALL TARGET (Therapeutically Applicable Research to Generate Effective Treatments) pilot project performed comprehensive genomic analyses (Affymetrix U133 Plus2.0 gene expression profiles and 500k + 100k single nucleotide polymorphism (SNP) chip analyses) to characterize approximately 200 cases of patients with higher risk ALL treated uniformly on the legacy COG P9906 trial. This pilot project has yielded major new insights into ALL biology and identified new therapeutic targets associated with a very high risk of relapse, including Janus kinase (JAK) mutations, for which we are now developing clinical trials. The COG ALL committee is determined to incorporate these novel findings into clinical trials for children with ALL quickly. The current proposal is designed to 1) validate the key TARGET findings from COG P9906 on cohorts of children with standard risk (SR) and HR B-precursor ALL treated on contemporary COG ALL protocols, b) determine the optimal assays to identify patients at diagnosis who may be candidates for JAK inhibitor therapy, and c) implement clinical testing for these markers in real-time on consecutively diagnosed patients enrolled on current COG ALL trials. This indeed presents a "Grand Opportunity" and paradigm shift for the COG to improve therapy for childhood ALL by integrating molecularly targeted agents into traditional chemotherapy regimens, an approach which we have shown to be very effective in children with Ph+ ALL. PUBLIC HEALTH RELEVANCE: Leukemia remains a major cause of morbidity and mortality in childhood. The Children's Oncology Group Acute Lymphoblastic Leukemia Committee and their collaborators have discovered a new leukemogenic pathway that may be amenable to treatment with more targeted therapies. This would permit clinicians to cure more children of their leukemia and potentially spare others of the substantial late effects that occur with traditional chemotherapy.


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: 2013 ( Subtotal = $0 )
2013	2010	NATIONAL CHILDHOOD CANCER FOUNDATION	POST OFFICE BOX 60012	ARCADIA	CA	91006	LOS ANGELES	USA	Trans-NIH Recovery Act Research Support	000	2	11/14/2012	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2011 ( Subtotal = $0 )
2011	2010	NATIONAL CHILDHOOD CANCER FOUNDATION	POST OFFICE BOX 60012	ARCADIA	CA	91006	LOS ANGELES	USA	Trans-NIH Recovery Act Research Support	000	2	3/31/2011	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2010 ( Subtotal = $876,194 )
2010	2010	NATIONAL CHILDHOOD CANCER FOUNDATION	POST OFFICE BOX 60012	ARCADIA	CA	91006	LOS ANGELES	USA	Trans-NIH Recovery Act Research Support	003	2	8/19/2010	NON-COMPETING CONTINUATION	$876,194
2010	2009	NATIONAL CHILDHOOD CANCER FOUNDATION	POST OFFICE BOX 60012	ARCADIA	CA	91006	LOS ANGELES	USA	Trans-NIH Recovery Act Research Support	000	1	2/19/2010	NEW	$0
2010	2009	NATIONAL CHILDHOOD CANCER FOUNDATION	POST OFFICE BOX 60012	ARCADIA	CA	91006	LOS ANGELES	USA	Trans-NIH Recovery Act Research Support	001	1	8/11/2010	NEW	$0
2010	2009	NATIONAL CHILDHOOD CANCER FOUNDATION	POST OFFICE BOX 60012	ARCADIA	CA	91006	LOS ANGELES	USA	Trans-NIH Recovery Act Research Support	002	1	8/12/2010	NEW	$0
														Subtotal = $876,194

Issue Date FY: 2009 ( Subtotal = $832,756 )
2009	2009	NATIONAL CHILDHOOD CANCER FOUNDATION	POST OFFICE BOX 60012	ARCADIA	CA	91006	LOS ANGELES	USA	Trans-NIH Recovery Act Research Support	000	1	9/29/2009	NEW	$832,756
														Subtotal = $832,756

Grand Total All Awards = $1,708,950

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TARGETED THERAPIES FOR CHILDHOOD ACUTE LYMPHOBLASTIC LEUKEMIA

Award Number: RC2CA148529

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/30/2009

PERIOD OF PERFORMANCE END DATE: 12/31/2012

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