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Venetoclax Crushed Tablet Solution Study for Hematologic Malignancies

This study is looking at how the body handles venetoclax when it's given as a crushed tablet dissolved in liquid. This is important because some patients, especially children, can't swallow whole tablets. Researchers want to understand how much venetoclax gets into the body and how quickly it's cleared when given this way. You might be able to join if you are under 39 years old, have a blood cancer like leukemia or lymphoma, and are already receiving venetoclax as a crushed tablet solution as part of your regular care. The study will measure the amount of venetoclax in your blood at different times after you take your dose to see how it's absorbed and cleared. The study aims to enroll 30 participants, but its current status is unclear.

Study design
This is an observational study, meaning participants will receive venetoclax as prescribed by their doctor. It aims to enroll 30 participants.
What's involved
You will have blood drawn at several specific times on one day between Days 5-12 after your venetoclax dose ramp-up. This includes before your dose and then 2, 5, 12, 18, and 24 hours after your dose.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT06131801

Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

Recruiting
Not specifiedAges 0–38Observational
Children's Hospital Medical Center, Cincinnati
~30 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested: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.

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)
Measured over 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.
+11 more outcomes measured

Conditions

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

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaB-Cell Non-Hodgkin LymphomaBurkitt LymphomaChronic Myeloid Leukemia, BCR-ABL1 PositiveDiffuse Large B-Cell LymphomaFollicular LymphomaHodgkin's GranulomaMalignant neoplasm of lymphoid, hematopoietic and/or related tissueMature T-Cell and NK-Cell Non-Hodgkin LymphomaMyeloproliferative NeoplasmNon-Hodgkin LymphomaPrimary cutaneous B-cell lymphomaT-Cell Non-Hodgkin Lymphoma

Where it's being run

5 sites across 5 states
Colorado1
Ohio1
Pennsylvania1
Texas1
Wisconsin1

Study leadership

  • Lauren Pommert, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

Site Public Contact
[email protected]
(513) 636-2799
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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

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

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

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

  • Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)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-∞)

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

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

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

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

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

  • Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)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-∞)

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