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BTK Inhibitor
Pirtobrutinib + Venetoclax for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By Yucai Wang, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how two drugs (pirtobrutinib and venetoclax) can treat Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and measure a blood test (minimal residual disease) to guide treatment length.
Who is the study for?
This trial is for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who haven't had previous treatments. Participants must be in good physical condition, have certain blood cell counts within a specific range, and agree to use birth control. People can't join if they've had recent heart issues, are pregnant/nursing, have HIV, or need certain medications that could interfere with the study drugs.
What is being tested?
The trial tests pirtobrutinib and venetoclax's effectiveness on patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. It also uses minimal residual disease detection to guide treatment duration. The goal is to see how these drugs stop cancer cells from growing by killing them or preventing division.
What are the potential side effects?
Possible side effects of pirtobrutinib and venetoclax include nausea, diarrhea, fatigue, risk of infection due to low white blood cell count (neutropenia), anemia (low red blood cell count), easy bruising/bleeding due to low platelets (thrombocytopenia), and potential liver function changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Undetected minimal residual disease (uMRD)
Secondary study objectives
Bone marrow uMRD rate
Complete response rate
Duration of response
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pirtobrutinib and venetoclax)Experimental Treatment11 Interventions
Patients receive pirtobrutinib and venetoclax PO on study. Patients also undergo CT, MRI, and PET scans during screening and on study. Patients also undergo bone marrow aspiration and bone marrow biopsy, and collection of blood, tissue, stool, and saliva samples on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1150
Biospecimen Collection
2004
Completed Phase 3
~2030
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Pirtobrutinib
2020
Completed Phase 1
~240
Positron Emission Tomography
2011
Completed Phase 2
~2200
Venetoclax
2019
Completed Phase 3
~2240
Echocardiography
2013
Completed Phase 4
~11580
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,045 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,889 Total Patients Enrolled
Yucai Wang, MD, PhDPrincipal InvestigatorMayo Clinic in Rochester
Yucai Wang, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
50 Total Patients Enrolled
Yucai Wang, M.D.Principal InvestigatorMayo Clinic in Rochester
Yucai WangPrincipal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled illnesses or serious heart, infection, or mental health issues.I do not have another cancer that needs treatment or shortens my life expectancy to 2 years or less.My condition has progressed to a more aggressive form.I am able to care for myself and perform daily activities.I am currently taking specific medications.I am 18 years old or older.I have not received any treatment for CLL/SLL.I have not received a live vaccine in the last 28 days.I have been diagnosed with CLL or SLL based on specific health criteria.My CLL/SLL cancer has spread to my brain or spinal cord.I have SLL with measurable B-cell clone in my blood or bone marrow.I meet at least one required condition for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pirtobrutinib and venetoclax)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.