Study of crushed venetoclax tablets dissolved in liquid for pediatric patients
A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies
This study tests if crushing venetoclax tablets and mixing them with liquid helps children with blood cancers absorb the medication better and stay safe while taking it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 0 Years to 38 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Aurora, Colorado and 4 other locations) |
| Trial ID | NCT06131801 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution for pediatric patients with hematologic malignancies. It aims to gather data on the drug's absorption and safety when administered in this manner, particularly for patients who cannot swallow tablets. Blood samples will be collected at multiple time points to assess how the drug behaves in the body. The study also explores potential differences in pharmacokinetics based on the method of administration, such as oral or via feeding tubes.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients under 39 years old with any hematologic malignancy who are prescribed venetoclax as a solution made from crushed tablets.
Not a fit: Patients who are pregnant or breastfeeding will not benefit from this study due to the potential risks associated with venetoclax.
Why it matters
Potential benefit: If successful, this study could provide critical information on the safe and effective use of venetoclax in pediatric patients who require alternative administration methods.
How similar studies have performed: While the use of venetoclax in pediatric populations is becoming more common, this specific approach of using crushed tablets dissolved in liquid has not been extensively studied, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aurora, Colorado and 4 other locations
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Lauren Pommert, MD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Site Public Contact
- Email: cancer@cchmc.org
- Phone: (513) 636-2799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.