← Back to Search

Monoclonal Antibodies

Pirtobrutinib-Obinutuzumab for Lymphoma

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of complete response after initial therapy

Secondary outcome measures

Event-free survival

Overall response rate

Overall survival

+4 more

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

2015

Completed Phase 3

~3250

Pirtobrutinib

2020

Completed Phase 1

~240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Inhye AhnLead Sponsor

1 Previous Clinical Trials

Loxo Oncology, Inc.Industry Sponsor

66 Previous Clinical Trials

9,809 Total Patients Enrolled

9 Trials studying Lymphoma

3,552 Patients Enrolled for Lymphoma

Inhye E Ahn, MDPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

45 Total Patients Enrolled

Frequently Asked Questions

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

Are prospective participants able to enroll in this research study at the present time?

"The clinical investigation, as outlined on clinicaltrials.gov, is presently not in the recruitment phase. Originally published on 9/1/2024 and last revised on 3/26/2024, it is worth mentioning that there are currently 1522 alternate trials actively seeking participants."

Answered by AI

Is Pirtobrutinib-Obinutuzumab considered to be a safe treatment option for individuals?

"The safety assessment for Pirtobrutinib-Obinutuzumab by the Power team has been rated as 2 on a scale ranging from 1 to 3. This rating is attributed to it being a Phase 2 trial, indicating existing safety data but lacking efficacy evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia

Inhye Ahn 2024. "Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06333262.

All > Paid Studies Boston