NCT06131801 Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
| NCT ID | NCT06131801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Hematologic Malignancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-15 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2023-11-15 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Lauren Pommert, MD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT06131801 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 38 Years, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06131801 currently recruiting?
Yes, NCT06131801 is actively recruiting participants. Contact the research team at cancer@cchmc.org for enrollment information.
Where is the NCT06131801 trial being conducted?
This trial is being conducted at Aurora, United States, Cincinnati, United States, Philadelphia, United States, Houston, United States and 1 additional location.
Who is sponsoring the NCT06131801 clinical trial?
NCT06131801 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Lauren Pommert, MD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 30 participants.