Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

Conditions

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

Eligibility Criteria

Sex

ALL

Age

0 Years - 38 Years

Healthy Volunteers

Not accepted

Interventions

• 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. — OTHER
  Participants will receive Venetoclax as prescribed by their treating provider as part of their clinical care.

Study Details

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

Key Dates

Start date

Nov 15, 2023

Status verified

Jun 2026

Primary completion

Dec 1, 2026

Completion

Dec 1, 2027

Study Design

Enrollment

30 participants (estimated)

Arms

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

Primary Outcome Measure

Clearance (CL) as measured by PK sampling (Peripheral Blood; Required) [ Time Frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax. ]

Central Contacts

• Site Public Contact
  (513) 636-2799
  [email protected]

Locations (5)

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