BENITIONSClinical Trial Intelligence

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

Фаза 2 Завершено NCT04401267

ЗаболеваниеHypertension, Osteonecrosis, Osteonecrosis Due to Drug
ФазаФаза 2
СпонсорSt. Jude Children's Research Hospital
СтатусЗавершено
Участники51 участн.
ВмешательствоIntensive Antihypertensive Therapy, Conventional Antihypertensive Therapy, Symptom Survey, Semi-structured interview
Дата начала15.10.2020
Дата завершения25.09.2023
Публикация результатов11.07.2024

Кратко

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 conventional antihypertensive control (targeted to the 90-95th percentile for age, sex, and height) on the incidence of radiographically extensive osteonecrosis in children and young adults receiving treatment for newly diagnosed acute lymphoblastic leukemia/lymphoma (ALL). Primary Objective * Compare the frequency of radiographically extensive osteonecrosis in patients receiving intensive compared to conventional antihypertensive therapy. Secondary Objectives * Evaluate the efficacy of intensive antihypertensive control compared to conventional antihypertensive control in the prevention of clinically significant (CTCAE Grade 2 or higher) and radiologically extensive osteonecrosis, overall and stratified by joints. * Compare the frequency of clinically significant and radiographically extensive osteonecrosis in patients receiving antihypertensive therapy and historical controls. * Compare blood pressures achieved in intensive and conventional arms using both pressures obtained as part of routine

Extensive Radiographic Osteonecrosis

during reinduction II therapy, approximately 9 months into therapy. · Participants

Conventional (Standard) Antihypertensive Therapy20 Participants
Intensive Antihypertensive Therapy21 Participants
Conventional (Standard) Antihypertensive Therapy1 Participants
Intensive Antihypertensive Therapy2 Participants
p-value0.7139

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