NCT06131801

Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 0 Years – 38 Years
• Healthy volunteers: Not accepted

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 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

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
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.	Participants will receive Venetoclax as prescribed by their treating provider as part of their clinical care.

Timeline

• Start date: 2023-11-15
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-11-14
• Last updated: 2026-02-18

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study