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Antihypertensive Therapy for Leukemia

Phase 2

Waitlist Available

Led By Seth E. Karol, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is 10 years of age or older at the time of enrollment on TOT17.

Must not have

Moderate-severe renal dysfunction (glomerular filtration rate <45 ml/min/1.73m2).

Down's syndrome (germline Trisomy 21) or other syndrome resulting in growth delay or alterations in stature.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up any time during leukemia therapy, approximately 2.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the frequency of radiographically extensive osteonecrosis in patients receiving intensive compared to conventional antihypertensive therapy.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include dizziness or lightheadedness due to lowered blood pressure from the antihypertensive treatments. Other risks could relate to the individual's response to medication adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 10 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is significantly reduced.

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I have Down's syndrome or a condition that affects my growth or height.

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I am not pregnant or breastfeeding and agree to use birth control during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ any time during leukemia therapy, approximately 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~any time during leukemia therapy, approximately 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and any time during leukemia therapy, approximately 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Extensive Radiographic Osteonecrosis

Secondary study objectives

Biomarker of Vascular Dysfunction - Arterial Elasticity (ml/mmHg)

Biomarker of Vascular Dysfunction - D-dimer (µg/mL)

Biomarker of Vascular Dysfunction - E-selectin (ng/mL)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met