Status:
RECRUITING
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Hematologic Malignancy
Leukemia
Eligibility:
All Genders
Up to 38 years
Brief 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 tabl...
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06131801
Start Date
November 15 2023
End Date
December 1 2027
Last Update
January 9 2026
Active Locations (5)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
4
Texas Children's Hospital
Houston, Texas, United States, 77030