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Hypertension Intervention to Reduce Osteonecrosis in Children with Acute Lymphoblastic Leukemia

Award Number: K08CA250418
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 04/01/2020
PERIOD OF PERFORMANCE END DATE: 03/31/2025

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Hypertension Intervention to Reduce Osteonecrosis in Children with Acute Lymphoblastic Leukemia - Project Summary Osteonecrosis (ON) is a common and severe side-effect of modern therapy for acute lymphoblastic leukemia (ALL). It most frequently impacts older children (≥10 years old) and young adults, with 15-45% of patients in these groups developing ON symptoms during therapy. Severe ON causes pain and limited mobility, requiring orthopedic surgery including joint replacement. There are currently no interventions which reduce this risk. This award application describes a career development plan to allow me to evolve into a successful independent clinical investigator and achieve my long-term goal of being an independent investigator leading clinical trials which reduce the toxicity of ALL therapy. The short-term goal of this project is to test an intervention for its ability to decrease osteonecrosis. Our preliminary preclinical data showed that intensive antihypertensive therapy reduces ON in this setting without impairing the anti-leukemia effect of chemotherapy. We will now test this in the clinic by evaluating the ability of intensive antihypertensive control (targeted to the 50-75th percentile for age, sex, and height) to reduce ON (as measured by 9 month MRI) compared to standard antihypertensive control (targeted to the 90-95th percentile) by randomizing 160 children and young adults ages 10-18.99 years enrolled on the Total 17 ALL trial to either intensive or standard antihypertensive control (Research Aim 1). Building on our preclinical data, we will also test the ability of biomarkers of vascular dysfunction to identify patients at highest risk of developing ON (Research Aim 2). Finally, we will measure patient-reported quality of life outcomes (PROs) to determine how both the intervention and osteonecrosis impact patients’ health-related quality of life (Research Aim 3). This career development award will also prepare me to achieve my long-term goals as an independent investigator. The practical experience of leading the proposed clinical trial, combined with didactic education in clinical trial design and structured mentorship, will increase my expertise as a clinical researcher (Training Aim 1). The award will also support training and mentorship in vascular physiology to improve both the analysis of the planned trial as well as to improve future trials (Training Aim 2). Finally, I will receive training, mentorship, and practical experience in the use of PROs to better implement these tools in future trials to best understand patient complications from therapy (Training Aim 3). This proposal may identify the first intervention to reduce ON in patients with ALL. Such an intervention would have implications for patients with other malignancies or autoimmune diseases who are also at risk of developing ON due to prolonged glucocorticoid treatment. Simultaneously, the training supported by the award will prepare me for a successful career as a clinician scientist to reduce therapy toxicity in children with ALL.


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 = $0 )
2025	2024	ST JUDE CHILDREN'S RESEARCH HOSPITAL INC	262 DANNY THOMAS PL	MEMPHIS	TN	38105	SHELBY	USA	Cancer Research Manpower	000	5	5/19/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $224,070 )
2024	2024	ST JUDE CHILDREN'S RESEARCH HOSPITAL INC	262 DANNY THOMAS PL	MEMPHIS	TN	38105	SHELBY	USA	Cancer Research Manpower	000	5	2/27/2024	NON-COMPETING CONTINUATION	$224,070
														Subtotal = $224,070

Issue Date FY: 2023 ( Subtotal = $224,070 )
2023	2023	ST. JUDE CHILDREN'S RESEARCH HOSPITAL, INC.	262 DANNY THOMAS PL	MEMPHIS	TN	38105	SHELBY	USA	Cancer Research Manpower	000	4	3/14/2023	NON-COMPETING CONTINUATION	$224,070
														Subtotal = $224,070

Issue Date FY: 2022 ( Subtotal = $225,570 )
2022	2022	ST. JUDE CHILDREN'S RESEARCH HOSPITAL, INC.	262 DANNY THOMAS PL	MEMPHIS	TN	38105	SHELBY	USA	Cancer Research Manpower	000	3	3/14/2022	NON-COMPETING CONTINUATION	$225,570
														Subtotal = $225,570

Issue Date FY: 2021 ( Subtotal = $226,070 )
2021	2021	ST. JUDE CHILDREN'S RESEARCH HOSPITAL, INC.	262 DANNY THOMAS PL	MEMPHIS	TN	38105	SHELBY	USA	Cancer Research Manpower	000	2	2/19/2021	NON-COMPETING CONTINUATION	$226,070
														Subtotal = $226,070

Issue Date FY: 2020 ( Subtotal = $224,610 )
2020	2020	ST. JUDE CHILDREN'S RESEARCH HOSPITAL, INC.	262 DANNY THOMAS PL	MEMPHIS	TN	38105	SHELBY	USA	Cancer Research Manpower	000	1	3/11/2020	NEW	$224,610
														Subtotal = $224,610

Grand Total All Awards = $1,124,390

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Hypertension Intervention to Reduce Osteonecrosis in Children with Acute Lymphoblastic Leukemia

Award Number: K08CA250418

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 04/01/2020

PERIOD OF PERFORMANCE END DATE: 03/31/2025

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