Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

Trial Title: Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

NCT ID: NCT06131801

Condition: Hematologic Malignancy
Leukemia
Lymphoma
Acute Lymphocytic Leukemia
ALL
Acute Myelogenous Leukemia
AML
Chronic Myelogenous Leukemia
CML
Myeloproliferative Neoplasm
Non Hodgkin Lymphoma
Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Burkitt Lymphoma
T-cell Lymphoma
B Cell Lymphoma
Peripheral T Cell Lymphoma
Cutaneous B-Cell Lymphoma

Conditions: Official terms:
Burkitt Lymphoma
Lymphoma
Leukemia
Neoplasms
Lymphoma, B-Cell
Leukemia, Myeloid
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Large B-Cell, Diffuse
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Hematologic Neoplasms
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myeloproliferative Disorders
Venetoclax

Conditions: Keywords:
Venetoclax
Pediatric AML
Pediatric Relapsed/Refractory AML

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: 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.
Description: Participants will receive Venetoclax as prescribed by their treating provider as part of their clinical care.
Arm group label: Children and Young Adults

Summary: 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

Detailed description: Peripheral blood will be drawn at multiple time points to evaluate venetoclax pharmacokinetics in patients who are receiving venetoclax solution made from crushed tablets as part of their oncology treatment.

Criteria for eligibility:

Study pop:
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. Patients must be <39 years of age at time of study enrollment.

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: All

Minimum age: 0 Years

Maximum age: 38 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cincinnati Children's Hospital Medical Center

Address:
City: Cincinnati
Zip: 45229
Country: United States

Start date: November 15, 2023

Completion date: December 1, 2027

Lead sponsor:
Agency: Children's Hospital Medical Center, Cincinnati
Agency class: Other

Source: Children's Hospital Medical Center, Cincinnati

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06131801