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Blood pressure drug may shield young cancer patients from crippling bone disease

NCT ID NCT04401267

Prevention Sponsor: St. Jude Children's Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This study tested whether keeping blood pressure in a lower, healthier range could prevent a painful bone condition called osteonecrosis in children and young adults being treated for leukemia. Fifty-one participants were randomly assigned to either intensive or standard blood pressure control. The goal was to see if tighter blood pressure management could reduce bone damage seen on MRI scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intensive Antihypertensive Therapy
What this could lead to
If successful, this could lead to a simple way to prevent painful bone damage in children undergoing leukemia treatment.
What could go wrong
This is a small, early-phase trial (51 participants) and results may not apply to all patients. Intensive blood pressure control also carries its own risks, like dizziness or low blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

51 people

The number who actually took part.

Started

Oct 2020

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient is being treated for newly diagnosed acute lymphoblastic leukemia or lymphoma (ALL) on the TOT17 protocol. Patients do not need to be hypertensive to enroll. * Patient is 10 years of age or older at the time of enrollment on TOT17. * Patient has completed ≤ 4 days of protocol therapy (patients are eligible on Day 4 of TOT17 therapy). Exclusion Criteria: * 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. * Chronic inability to ambulate. Patients with limitations in movement due to acute complications of leukemia/lymphoma are not excluded. * Permanent contraindication to MRI evaluation. * Participants who are pregnant or lactating. Males or females of reproductive potential must agree to use effective contraception for the duration of study participation. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia hypertensive disorder lymphoma osteonecrosis Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension Osteonecrosis Osteonecrosis due to drug

Contacts and locations

Locations

  • St. Jude Affiliate Clinic - Novant Health Hemby Children's Hospital

    Charlotte, North Carolina, 28204, United States

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

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