Actively Recruiting
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-02-18
30
Participants Needed
5
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 under 39 years of age at the time of enrollment
- Patients may have any hematologic malignancy diagnosis
- 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 not allowed due to potential risks from venetoclax
- Breastfeeding must be stopped if the mother is treated with venetoclax
- Males and females who can have children 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
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
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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