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BTK Inhibitor

Pirtobrutinib + Venetoclax for Chronic Lymphocytic Leukemia

Phase 2
Recruiting
Led By Yucai Wang, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up fom registration to death due to any cause, assessed up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.
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I have not received any treatment for CLL/SLL.
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I have SLL with measurable B-cell clone in my blood or bone marrow.
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I have been diagnosed with CLL or SLL based on specific health criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~fom registration to death due to any cause, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and fom registration to death due to any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Undetected minimal residual disease (uMRD)
Secondary outcome measures
Bone marrow uMRD rate
Complete response rate
Duration of response
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pirtobrutinib and venetoclax)Experimental Treatment10 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
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Venetoclax
2019
Completed Phase 3
~1990
Echocardiography
2013
Completed Phase 4
~11670
Pirtobrutinib
2020
Completed Phase 1
~240
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Positron Emission Tomography
2008
Completed Phase 2
~2260
Computed Tomography
2017
Completed Phase 2
~2790
Biospecimen Collection
2004
Completed Phase 2
~1920

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,302 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,440 Total Patients Enrolled
Yucai Wang, M.D.Principal InvestigatorMayo Clinic in Rochester

Media Library

Pirtobrutinib (BTK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05677919 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Treatment (pirtobrutinib and venetoclax)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Pirtobrutinib Highlights & Side Effects. Trial Name: NCT05677919 — Phase 2
Pirtobrutinib (BTK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05677919 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings remaining for prospective participants?

"According to the information on clinicaltrials.gov, this clinical trial is not currently recruiting patients. It was first put up for public view on January 17th 2023 and last revised December 28th 2022. At present, there are 1,491 other trials actively searching for participants."

Answered by AI

Has the FDA officially endorsed pirtobrutinib and venetoclax for therapeutic purposes?

"The safety of the combination regimen (pirtobrutinib and venetoclax) was given a rating of 2, as this is only a phase two trial; thus, there is some data for health protection but none that prove efficacy."

Answered by AI
~8 spots leftby Jul 2024