Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma
Фаза 2
Завершено
NCT04401267
| Заболевание | Hypertension, Osteonecrosis, Osteonecrosis Due to Drug |
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| Фаза | Фаза 2 |
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| Спонсор | St. Jude Children's Research Hospital |
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| Статус | Завершено |
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| Участники | 51 участн. |
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| Вмешательство | Intensive Antihypertensive Therapy, Conventional Antihypertensive Therapy, Symptom Survey, Semi-structured interview |
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| Дата начала | 15.10.2020 |
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| Дата завершения | 25.09.2023 |
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| Публикация результатов | 11.07.2024 |
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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 Therapy | 20 Participants |
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| Intensive Antihypertensive Therapy | 21 Participants |
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| Conventional (Standard) Antihypertensive Therapy | 1 Participants |
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| Intensive Antihypertensive Therapy | 2 Participants |
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