Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

Why are we doing this research?

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.

Venetoclax PK: A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies.

Who can participate?

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 a central line for PK blood draws
Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment
Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.
Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.

Exclusion Criteria:

Pregnant women are excluded from this study because venetoclax has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.
Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.

Ages

0 Years to 38 Years

Conditions

Leukemia ALL New Diagnosis
Adult - Leukemia ALL New Diagnosis
Leukemia ALL Relapse - Refractory
Adult - Leukemia ALL Relapse - Refractory
Leukemia AML New Diagnosis
Adult - Leukemia AML New Diagnosis
Leukemia AML Relapse - Refractory
Adult - Leukemia AML Relapse - Refractory
Leukemia CML Relapse - Refractory
Adult - Leukemia CML Relapse - Refractory
Adult - Leukemia CML New Diagnosis
Leukemia CML New Diagnosis
Lymphoma Hodgkin New Diagnosis
Adult - Lymphoma Hodgkin New Diagnosis
Lymphoma Hodgkin Relapse - Refractory
Adult - Lymphoma Hodgkin Relapse - Refractory
Lymphoma Non-Hodgkin Relapse - Refractory
Lymphoma Non-Hodgkin New Diagnosis
Adult - Lymphoma Non-Hodgkin Relapse - Refractory
Adult - Lymphoma Non-Hodgkin New Diagnosis

Clinical Trials / Research StudiesClinical Trials / Research Studies