Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma
Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
This is a randomized unblinded Phase II clinical trial evaluating the impact of intensive
antihypertensive control (targeted to the 50-75th percentile for age, sex, and height)
compared to conventional antihypertensive control (targeted to the 90-95th percentile for
age, sex, and height) on the incidence of radiographically extensive osteonecrosis in
children and young adults receiving treatment for newly diagnosed acute lymphoblastic
leukemia/lymphoma (ALL).
Primary Objective
- Compare the frequency of radiographically extensive osteonecrosis in patients receiving
intensive compared to conventional antihypertensive therapy.
Secondary Objectives
- Evaluate the efficacy of intensive antihypertensive control compared to conventional
antihypertensive control in the prevention of clinically significant (CTCAE Grade 2 or
higher) and radiologically extensive osteonecrosis, overall and stratified by joints.
- Compare the frequency of clinically significant and radiographically extensive
osteonecrosis in patients receiving antihypertensive therapy and historical controls.
- Compare blood pressures achieved in intensive and conventional arms using both pressures
obtained as part of routine patient care and ambulatory blood pressure monitoring.
- Compare levels of vascular dysfunction as measured physiologically, radiographically,
and in blood samples in patients receiving intensive compared to standard
antihypertensive therapy.
Exploratory Objectives
- Identify predictive patterns of blood biomarkers which identify patients at high- risk
of developing clinically significant osteonecrosis.
- Identify MRI findings during late induction which correlate with osteonecrosis lesions
seen during reinduction.
- Identify patterns of diurnal blood pressure variation as measured by ambulatory blood
pressure monitoring associated with the later development of osteonecrosis.
- Compare induction blood pressure control and intervention arm to echocardiographic
changes at reinduction II.
- Evaluate patient-reported, health-related quality of life in patients during induction
and after 1.5 years of therapy when many experience the symptoms of osteonecrosis.