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Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
NCT06131801 · Children's Hospital Medical Center, Cincinnati
In plain English
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Official title
A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 30 participants
Age groups: child, adult
Timeline
Starts: 2023-11-15
Estimated completion: 2027-12-01
Last updated: 2026-02-18
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.
Primary outcomes
- • Clearance (CL) as measured by PK sampling (Peripheral Blood; Required) (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.)
- • Clearance (CL) as measured by PK sampling (Peripheral Blood; Required) (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.)
- • Clearance (CL) as measured by PK sampling (Peripheral Blood; Required) (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.)
Sponsor
Children's Hospital Medical Center, Cincinnati · other
Contacts & investigators
ContactSite Public Contact · contact · cancer@cchmc.org · (513) 636-2799
InvestigatorLauren Pommert, MD · principal_investigator, Children's Hospital Medical Center, Cincinnati
All locations (5)
Children's Hospital ColoradoRecruiting
Aurora, Colorado, United States
Cincinnati Children's Hospital Medical CenterRecruiting
Cincinnati, Ohio, United States
Children's Hospital of PhiladelphiaNot Yet Recruiting
Philadelphia, Pennsylvania, United States
Texas Children's HospitalRecruiting
Houston, Texas, United States
Children's Hospital of WisconsinRecruiting
Milwaukee, Wisconsin, United States