Status:
COMPLETED
Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hypertension
Osteonecrosis
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief 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 conventiona...
Detailed Description
Patient randomization will be stratified based on patient's location (Memphis vs. other), use of antihypertensives prior to randomization, and factors known to influence osteonecrosis risk, specifical...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2025
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04401267
Start Date
October 15 2020
End Date
October 7 2025
Last Update
November 3 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Jude Affiliate Clinic - Novant Health Hemby Children's Hospital
Charlotte, North Carolina, United States, 28204
2
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105