Health Trials

Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

ConditionsHematologic MalignancyLeukemiaLymphomaAcute Lymphocytic LeukemiaALLAcute Myelogenous LeukemiaAMLChronic Myelogenous LeukemiaCMLMyeloproliferative NeoplasmNon Hodgkin LymphomaHodgkin LymphomaDiffuse Large B Cell LymphomaFollicular LymphomaBurkitt LymphomaT-cell LymphomaB Cell LymphomaPeripheral T Cell LymphomaCutaneous B-Cell Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-38
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

5
Children's Hospital Colorado80045, AuroraColorado, United States
Cincinnati Children's Hospital Medical Center45229, CincinnatiOhio, United States
Children's Hospital of Philadelphia19104, PhiladelphiaPennsylvania, United States
Texas Children's Hospital77030, HoustonTexas, United States

Sponsors and collaborators

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Source ClinicalTrials.gov