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.
Key facts
- Who runs it
- Children's Hospital Medical Center, Cincinnati
- Where
- Atlanta, Aurora, Cincinnati, Houston, Milwaukee, and Philadelphia, United StatesSee the 6 sites
- Trial code
- Registry title
- Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 15 Nov 2023
- Expected to end
- 1 Dec 2027
- Type of study
- Observational
- Treatments tested
- 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.
- Record updated
- 29 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and young adults with a blood cancer who are already taking venetoclax as a liquid made from crushed tablets.
- Age
- Under 39 years (0 to 38 years).
- Sex
- All sexes can join.
- Disease stage
- Any blood cancer (hematologic malignancy).
- Earlier treatment
- Must be getting venetoclax as a solution made from crushed tablets, by mouth, nasogastric (NG) tube or G-tube, as prescribed by their oncologist. It can be the only drug or given with other chemotherapy.
Main reasons for not taking part
- Pregnant women cannot join.
- People who could have children cannot join unless they agree to use effective contraception during the study and for six months after.
- Weight under 5.5 kg (12 lb).
- No existing venous or arterial access line for blood draws.
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in United States
- Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlanta, United StatesContact: Himalee Sabnis, MD, MSNot yet recruiting
- Children's Hospital ColoradoAurora, United StatesContact: Kelly Faulk, MDTaking people
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
- Texas Children's HospitalHouston, United StatesContact: Michelle Redell, MDTaking people
- Children's Hospital of WisconsinMilwaukee, United StatesContact: Kira MielkeTaking people
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Tasleema PatelTaking people
About the trial
What the trial wants to find out
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
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
The group in the trial
- Children and Young Adults
Children and Young Adults who are prescribed venetoclax made from crushed tablets as part of their clinical care.
Treatment: 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.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies
- Plain-language title
- Studies how the body processes venetoclax tablets crushed into a liquid in young patientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06131801, who can take part
- Record updated
- 29 October 2026