Study of crushed venetoclax tablets dissolved in liquid for pediatric patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution for pediatric patients with hematologic malignancies. It aims to gather data on the drug's absorption and safety when administered in this manner, particularly for patients who cannot swallow tablets. Blood samples will be collected at multiple time points to assess how the drug behaves in the body. The study also explores potential differences in pharmacokinetics based on the method of administration, such as oral or via feeding tubes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• Texas Children's Hospital
  Houston, Texas, United States Recruiting
• Children's Hospital of Wisconsin
  Milwaukee, Wisconsin, United States Recruiting
• Children's Healthcare of Atlanta - Arthur M. Blank Hospital
  Atlanta, Georgia, United States Not yet recruiting

Study contacts

• Principal investigator: Lauren Pommert, MD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Site Public Contact
• Email: cancer@cchmc.org
• Phone: (513) 636-2799

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.