Antihypertensive Therapy for Leukemia

Recruiting in Palo Alto (17 mi)

+2 other locations

Seth Karol, MD - St. Jude Children's ...

Overseen bySeth E. Karol, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: St. Jude Children's Research Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Seth E. Karol, MD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for children and young adults over 10 years old with newly diagnosed acute lymphoblastic leukemia/lymphoma, who are not hypertensive. They must be able to undergo MRI scans, not have severe kidney issues or growth-altering syndromes, and agree to use contraception if applicable.

Inclusion Criteria

I am 10 years old or older.

I have completed up to 4 days of my current treatment plan.

I am currently being treated for ALL following the TOT17 protocol.

Exclusion Criteria

I cannot walk due to long-term conditions, not because of recent leukemia/lymphoma complications.

My kidney function is significantly reduced.

Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

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Treatment Details

Interventions

Conventional Antihypertensive Therapy (Other)
Intensive Antihypertensive Therapy (Other)

Trial OverviewThe study compares intensive antihypertensive therapy (aiming for lower blood pressure targets) versus conventional therapy (higher targets) in reducing osteonecrosis risk during leukemia/lymphoma treatment. It includes surveys, interviews, and monitoring of blood pressure and vascular health.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Intensive Antihypertensive TherapyExperimental Treatment3 Interventions

Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.

Group II: Conventional Antihypertensive TherapyActive Control3 Interventions

Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.