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NCT Number: NCT06131801

Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

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

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Key information

Conditions

Hematologic Malignancy ALL AML Acute Lymphocytic Leukemia Acute Myelogenous Leukemia B Cell Lymphoma Bone Marrow Diseases Burkitt Lymphoma CML Chronic Disease Chronic Myelogenous Leukemia Cutaneous B-Cell Lymphoma DNA Virus Infections Diffuse Large B Cell Lymphoma Disease Attributes Epstein-Barr Virus Infections Follicular Lymphoma Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Herpesviridae Infections Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Myeloproliferative Disorders Myeloproliferative Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms by Site Non Hodgkin Lymphoma Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral T Cell Lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma T-cell Lymphoma Tumor Virus Infections Virus Diseases

Age range

0 year–38 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other

Participants will receive Venetoclax as prescribed by their treating provider as part of their clinical care.

Primary outcomes

  1. Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)

    Time frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.

    PK parameters of venetoclax will be described in peripheral blood including: the observed peak plasma concentration (Cmax)

  2. Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)

    Time frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.

    PK parameters of venetoclax will be described in peripheral blood including: the time to peak (Tmax)

  3. Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)

    Time frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.

    PK parameters of venetoclax will be described in peripheral blood including: the apparent terminal phase elimination rate constant (β)

  4. Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)

    Time frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.

    PK parameters of venetoclax will be described in peripheral blood including: the terminal-phase elimination half-life (T1/2)

  5. Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)

    Time frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.

    PK parameters of venetoclax will be described in peripheral blood including: the areas under plasma concentration curve (AUC) over a 24-hour dose interval (AUC0-24) or for infinite time (AUC0-∞)

  6. Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)

    Time frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.

    PK parameters of venetoclax will be described in peripheral blood including: oral clearance (CL/F) of venetoclax

  7. Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)

    Time frame: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.

    PK parameters of venetoclax will be described in cerebral spinal fluid including: the observed peak plasma concentration (Cmax)

  8. Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)

    Time frame: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.

    PK parameters of venetoclax will be described in cerebral spinal fluid including: the time to peak (Tmax)

  9. Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)

    Time frame: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.

    PK parameters of venetoclax will be described in cerebral spinal fluid including: the apparent terminal phase elimination rate constant (β)

  10. Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)

    Time frame: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.

    PK parameters of venetoclax will be described in cerebral spinal fluid including: the terminal-phase elimination half-life (T1/2)

  11. Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)

    Time frame: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.

    PK parameters of venetoclax will be described in cerebral spinal fluid including: the areas under plasma concentration curve (AUC) over a 24-hour dose interval (AUC0-24) or for infinite time (AUC0-∞)

  12. Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)

    Time frame: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.

    PK parameters of venetoclax will be described in cerebral spinal fluid including: oral clearance (CL/F)

Study contacts

Contact information is provided by the study sponsor or research team.

Site Public Contact

CONTACT

[email protected]

(513) 636-2799

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 14, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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