Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

October 15, 2020

Primary Completion Date

September 25, 2023

Study Completion Date

October 31, 2025

Conditions
HypertensionOsteonecrosisOsteonecrosis Due to Drug
Interventions
DRUG

Intensive Antihypertensive Therapy

Receives intensive antihypertensive therapy

DRUG

Conventional Antihypertensive Therapy

Receives conventional antihypertensive therapy

OTHER

Symptom Survey

The symptom survey is comprised of the PROMIS Ped 25 profile, PROMIS pain interference 8a, PROMIS physical activity 8a, and PROMIS mobility 8a during induction (day 23-28), during week 17 of continuation (+/- 2 weeks), and continuation week 49 (+/- 3 weeks).

OTHER

Semi-structured interview

Patients will be interviewed by a trained examiner about their treatment and symptom burden on Week 49 of TOT17 Continuation Therapy. The interview will be recorded and will take about 30-45 minutes.

Trial Locations (2)

28204

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

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

St. Jude Children's Research Hospital

OTHER