Studies how the body processes venetoclax tablets crushed into a liquid in young patients
Measures venetoclax levels in children and young adults with blood cancers who take crushed tablets.
Plain-language title generated from the registry record
Registry title: Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Key facts
- Where
- Atlanta, Aurora, Cincinnati, Houston, Milwaukee, and Philadelphia, United StatesSee the 6 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 0 and 38 years old?
Source: NCT06131801, who can take part
Where in United States
- Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlanta, United StatesNot yet recruiting
- Children's Hospital ColoradoAurora, United StatesTaking people
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
- Texas Children's HospitalHouston, United StatesTaking people
- Children's Hospital of WisconsinMilwaukee, United StatesTaking people
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Children's Hospital Medical Center, Cincinnati
- Trial code
- NCT06131801
- Record updated
- 29 October 2026
- Original description
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.Read full original descriptionShow less
A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies
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
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.