Hematologic MalignancyNCT06131801
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
An observational study of Hematologic Malignancy and Leukemia, run by Children's Hospital Medical Center, Cincinnati at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 38 years
- Conditions the study is for
- Hematologic Malignancy, Leukemia, Lymphoma
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Nov 2023to 1 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 38 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
Children's Healthcare of Atlanta - Arthur M. Blank Hospital
Atlanta, Georgia, 30329
Himalee Sabnis, MD, MS, 404-785-3627 ext. 57922, Himalee.sabnis@choa.org
Himalee Sabnis, MD, MS
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Kelly Faulk, MD, 720-777-5771, Kelly.Faulk@childrenscolorado.org
Kelly Faulk, MD
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Michelle Redell, MD, 832-822-4242, mlredell@texaschildrens.org
Grace Anand, 832-824-7705, gxanand@texaschildrens.org
- Recruiting
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Kira Mielke, kmielke@mcw.edu
Kara Nelson, knelson@mcw.edu
- Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Tasleema Patel, 917-818-6971, patelt6@chop.edu
Sarah Tasian, MD
About this study
Official title: A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies
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
Read more
- 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
Read the 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.
- Conditions
- Hematologic Malignancy, Leukemia, Lymphoma, Acute Lymphocytic Leukemia, ALL, Acute Myelogenous Leukemia
- Being 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.
- Keywords
- Venetoclax, Pediatric AML, Pediatric Relapsed/Refractory AML
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myeloproliferative Disorders, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Children and Young Adults | Children and Young Adults who are prescribed venetoclax made from crushed tablets as part of their clinical care. Receives: Other: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)
PK parameters of venetoclax will be described in peripheral blood including: the observed peak plasma concentration (Cmax)
Measured: 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)
PK parameters of venetoclax will be described in peripheral blood including: the time to peak (Tmax)
Measured: 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)
PK parameters of venetoclax will be described in peripheral blood including: the apparent terminal phase elimination rate constant (β)
Measured: 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)
PK parameters of venetoclax will be described in peripheral blood including: the terminal-phase elimination half-life (T1/2)
Measured: 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)
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-∞)
Measured: 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)
PK parameters of venetoclax will be described in peripheral blood including: oral clearance (CL/F) of venetoclax
Measured: 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)
PK parameters of venetoclax will be described in cerebral spinal fluid including: the observed peak plasma concentration (Cmax)
Measured: 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)
PK parameters of venetoclax will be described in cerebral spinal fluid including: the time to peak (Tmax)
Measured: 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)
PK parameters of venetoclax will be described in cerebral spinal fluid including: the apparent terminal phase elimination rate constant (β)
Measured: 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)
PK parameters of venetoclax will be described in cerebral spinal fluid including: the terminal-phase elimination half-life (T1/2)
Measured: 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)
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-∞)
Measured: 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)
PK parameters of venetoclax will be described in cerebral spinal fluid including: oral clearance (CL/F)
Measured: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start15 Nov 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Pommert, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131801
- Sponsor's protocol ID
- Venetoclax PK
- Status last verified
- Sep 2026
- First submitted
- 24 Oct 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No