Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Hodgkin Lymphoma; AML; Acute Myelogenous Leukemia; B Cell Lymphoma; ALL; Chronic Myelogenous Leukemia; Non Hodgkin Lymphoma; Leukemia; Cutaneous B-Cell Lymphoma; Hematologic Malignancy; T-cell Lymphoma; CML; Acute Lymphocytic Leukemia; Myeloproliferative Neoplasm; Follicular Lymphoma; Lymphoma; Burkitt Lymphoma; Peripheral T Cell Lymphoma; Diffuse Large B Cell Lymphoma

Treatments: Other: 1. Drug: The Venetoclax PK study is collecting bodily fluid samples (ie., whole blood and optional cerebrospinal fluid) of patients prescribed venetoclax as crushed tablets per standard of care.

Study type: Observational

Funder types: Other

Identifiers

NCT06131801

Venetoclax PK

Details and patient eligibility

About

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 evaluate the safety of crushed venetoclax tablets administered as an oral solution
• 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

Full description

Peripheral blood will be drawn at multiple time points to evaluate venetoclax pharmacokinetics in patients who are receiving venetoclax solution made from crushed tablets as part of their oncology treatment.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 38 years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

30 participants in 1 patient group

Children and Young Adults

Description:

Children and Young Adults who are prescribed venetoclax made from crushed tablets as part of their clinical care.

Treatment:

Other: 1. Drug: The Venetoclax PK study is collecting bodily fluid samples (ie., whole blood and optional cerebrospinal fluid) of patients prescribed venetoclax as crushed tablets per standard of care.