Actively Recruiting
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Blood Cancers
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-06-04
30
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics of venetoclax when tablets are crushed and dissolved into a liquid solution for children and young adults with blood cancers. This study aims to understand how the body processes venetoclax in this form, as no data currently exists for crushed tablets dissolved in liquid. The study also looks at safety, how different administration routes affect drug levels, and venetoclax concentration in the cerebrospinal fluid. Participants receive venetoclax made from crushed tablets as prescribed by their oncologist, either by mouth or through feeding tubes like nasogastric or gastrostomy tubes. Blood samples are collected at multiple time points between days 5 and 12 after dose ramp-up to measure drug clearance. Optional cerebrospinal fluid samples may also be collected around days 8, 15, 22, or 28 for additional analysis. During the study, peripheral blood is drawn to evaluate venetoclax levels, with optional cerebrospinal fluid sampling for some participants. Researchers monitor drug clearance and safety while patients continue their cancer treatment, which may include other chemotherapy drugs. The study includes patients from birth up to 38 years old, involving multiple visits to collect samples over several weeks to assess how the drug behaves in the body when given as a liquid solution.
CONDITIONS
Brief Title
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be younger than 39 years old at enrollment
- Patients must have a diagnosis of any hematologic malignancy
- Patients must have an existing venous or arterial access line for blood draws
- Patients must weigh at least 5.5 kg at enrollment
- Patients must be receiving venetoclax as a solution made from crushed tablets by mouth or feeding tube
- Patients may receive venetoclax alone or with other chemotherapy drugs
You will not qualify if you...
- Pregnant women are excluded due to potential risks of venetoclax
- Breastfeeding mothers should stop nursing if treated with venetoclax
- Patients of reproductive potential must use effective contraception during treatment and for six months after
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 4 weeks following venetoclax dose ramp-up
Participants who receive venetoclax made from crushed tablets as part of their clinical care have peripheral blood and optional cerebrospinal fluid samples collected to evaluate pharmacokinetics.
1 intensive blood sampling day with multiple draws and up to 4 optional cerebrospinal fluid collection visits around Days 8, 15, 22, and/or 28
Trial Site Locations
Total: 5 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
4
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
5
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
S
Site Public Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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