Recruiting

Venetoclax

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06131801

Conditions

Hematologic Malignancy

Leukemia

Lymphoma

Acute Lymphocytic Leukemia

ALL

Eligibility Criteria

Sex: All

Age: 0 - 38

Healthy Volunteers: Not accepted

Interventions

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.

Study Details

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

Conditions

Hematologic Malignancy

Leukemia

Lymphoma

Acute Lymphocytic Leukemia

ALL

Study ID

NCT06131801

Start date

Nov 15, 2023

Status verified date

Jun, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 38

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Children and Young Adults

Children and Young Adults who are prescribed venetoclax made from crushed tablets as part of their clinical care.

Interventions

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.

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

Primary outcome measure

  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Site Public Contact

(513) 636-2799cancer@cchmc.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kelly Faulk, MD

(720) 777-5771Kelly.Faulk@childrenscolorado.org

Principal Investigator:

Kelly Faulk, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Michelle Redell, MD

(832) 822-4242mlredell@texaschildrens.org

Grace Anand

832-824-7705gxanand@texaschildrens.org

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Kira Mielke

kmielke@mcw.edu

Kara Nelson

knelson@mcw.edu

Principal Investigator:

Michael Burke, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Venetoclax
  • Pediatric AML
  • Pediatric Relapsed/Refractory AML

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-06-04.