Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

Recruiting Observational Study
Hematologic Malignancy Leukemia Lymphoma Acute Lymphocytic Leukemia ALL Acute Myelogenous Leukemia AML Chronic Myelogenous Leukemia CML Myeloproliferative Neoplasm Non Hodgkin Lymphoma Hodgkin Lymphoma Diffuse Large B Cell Lymphoma Follicular Lymphoma Burkitt Lymphoma T-cell Lymphoma B Cell Lymphoma Peripheral T Cell Lymphoma Cutaneous B-Cell Lymphoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
0 – 38
Sex
Any
Study type
Observational
Participants needed
30 (estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age: Patients must be \<39 years of age at time of study enrollment * Diagnosis: Patients may have a diagnosis of any hematologic malignancy * Central access: Patients must have an existing venous or arterial access line for PK blood draws * Weight requirement: Patients must w…
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