Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma
Hypertension, Osteonecrosis, Osteonecrosis Due to Drug
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Acute Lymphoblastic Leukemia, Children, Hypertension, Osteonecrosis, Osteonecrosis Due to Drug
Eligibility Criteria
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.
Sites / Locations
- St. Jude Affiliate Clinic - Novant Health Hemby Children's Hospital
- St. Jude Children's Research Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intensive Antihypertensive Therapy
Conventional Antihypertensive Therapy
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.
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.