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Children and Young Adults for Leukemia
Study Summary
The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown. Primary Objectives • To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution Secondary Objectives To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube) To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution
- Leukemia
- Blood Cancers
- Myeloproliferative Neoplasms
- Burkitt Lymphoma
- Acute Myeloid Leukemia
- Chronic Myeloid Leukemia
- Hodgkin's Lymphoma
- Non-Hodgkin's Lymphoma
- Acute Lymphoblastic Leukemia
- Lymphoma
- T-Cell Lymphoma
- B-Cell Lymphoma
- Follicular Lymphoma
- Peripheral T-Cell Lymphoma
- Cutaneous B-Cell Lymphoma
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT02005471Trial Design
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