← Back to Search

Monoclonal Antibodies

Pirtobrutinib + Obinutuzumab for Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Led By Inhye E Ahn, MD

Research Sponsored by Inhye Ahn

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 5 years after the last enrollment

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test the effectiveness of a combination treatment of pirtobrutinib and obinutuzumab given for 1 year as the initial treatment for chronic lymphocytic leukemia

Who is the study for?

Adults over 18 with chronic lymphocytic leukemia or small lymphocytic lymphoma who need treatment and meet specific health guidelines. They should have no prior CLL/SLL treatments, be able to take pills, and have measurable disease. Excluded are those with other serious illnesses, recent major surgery, active infections like hepatitis B/C or HIV, bleeding disorders, significant heart issues, or pregnant/breastfeeding women.

What is being tested?

The trial is testing a combination of two drugs—Pirtobrutinib and Obinutuzumab—for about a year as the first line of attack against chronic lymphocytic leukemia/small lymphocytic lymphoma. The effectiveness of this fixed-duration therapy given over 12 cycles will be evaluated.

What are the potential side effects?

Potential side effects may include diarrhea, fatigue, muscle pains, nausea; low blood counts leading to increased infection risk; allergic reactions during infusion; liver enzyme changes; and possibly others not listed here.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years after the last enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years after the last enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years after the last enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of complete response after initial therapy

Secondary study objectives

Event-free survival

Overall response rate

Overall survival

+4 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: Pirtobrutinib-ObinutuzumabExperimental Treatment2 Interventions

Eligible participants will receive initial treatment with pirtobrutinib and obinutuzumab for 12 cycles. Participants with progressive chronic lymphocytuc leukemia or small lymphocytic lymphoma during the off-treatment follow-up will receive continuous pirtobrutinib monotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Obinutuzumab

2014

Completed Phase 3

~3470

Pirtobrutinib

2020

Completed Phase 1

~240