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NCT06131801 · ClinicalTrials.gov registry record
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
A clinical trial of Lymphoma and Leukemia, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- 30
- Enrollment target
- 5
- Study locations
NCT06131801 is a study of Lymphoma and Leukemia that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 30 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (94% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT06131801, a study of Lymphoma and Leukemia, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- 30 participants
- Enrollment target
- 5
- Study locations
Study 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
Conditions Studied
Interventions
- 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 Locations (5)
Colorado
- Children's Hospital Colorado - Aurora
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Texas
- Texas Children's Hospital - Houston
Wisconsin
- Children's Hospital of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-11-15 |
| Est. Completion | 2027-12-01 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06131801
The ClinicalTrials.gov registry entry for NCT06131801 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (94% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which 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. is the first listed.
NCT06131801 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Colorado, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06131801 about?
NCT06131801 is a clinical study titled "Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution". 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...
What is the current status of trial NCT06131801?
This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2023-11-15. Estimated completion is 2027-12-01.
What conditions does trial NCT06131801 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia, Hematologic Malignancy, Myeloproliferative Neoplasm, Acute Myelogenous Leukemia.
What interventions are being tested in trial NCT06131801?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT06131801?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06131801 being conducted?
This trial has 5 study locations across Colorado, Ohio, Pennsylvania, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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