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NCT06131801 | RECRUITING | Hematologic Malignancy

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

Children's Hospital Medical Center, Cincinnati

Brief 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

Condition or disease

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

Intervention/treatment

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.

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 30 participants
Official Title : A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies
Actual Study Start Date : 2023-11-15
Estimated Primary Completion Date : 2026-12-01
Estimated Study Completion Date : 2027-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 0 Years to 38 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

Location Details

NCT06131801

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How to Participate

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Locations

RECRUITING

United States, Ohio

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229