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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 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

Find a Location

Who is running the clinical trial?

Inhye AhnLead Sponsor
1 Previous Clinical Trials
Loxo Oncology, Inc.Industry Sponsor
71 Previous Clinical Trials
11,019 Total Patients Enrolled
10 Trials studying Lymphoma
3,762 Patients Enrolled for Lymphoma
Inhye E Ahn, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
45 Total Patients Enrolled
~40 spots leftby Feb 2027
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