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BTK Inhibitor

Pirtobrutinib + Venetoclax for Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Led By Yucai Wang, M.D., Ph.D.

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 fom registration to death due to any cause, assessed 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 ~ fom registration to death due to any cause, assessed up to 5 years

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

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 more

Awards & 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 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

Biospecimen Collection

2004

Completed Phase 3

~2020

Bone Marrow Aspiration

2011

Completed Phase 2

~1740