RecruitingPhase 2NCT06333262

Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia

A Phase 2 Study of Fixed Duration Therapy With Pirtobrutinib and Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia (POP)


Sponsor

Inhye Ahn

Enrollment

60 participants

Start Date

Apr 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — pirtobrutinib (a targeted oral drug that blocks a protein cancer cells need to grow) and obinutuzumab (an antibody that marks cancer cells for destruction by the immune system) — in people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), both slow-growing blood cancers. The treatment is designed to be given for a fixed duration rather than indefinitely, which may reduce side effects and treatment burden. **You may be eligible if:** - You have been diagnosed with CLL or SLL according to established medical guidelines - You have measurable disease and an indication that treatment is now needed - You have not yet received any systemic therapy for CLL or SLL - You are 18 or older in sufficient health to participate - You are able to take oral medications **You may NOT be eligible if:** - Your CLL has transformed into a more aggressive lymphoma (Richter's transformation), or cancer has spread to the central nervous system - You have a history of bleeding disorders, recent stroke, or brain hemorrhage in the past 6 months - You have significant heart problems (uncontrolled arrhythmia, severe heart failure, or weak heart function) - You have another active cancer with a life expectancy of less than 2 years - You are currently on other investigational agents Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPirtobrutinib

Initial treatment: \- Pirtobrutinib 200 mg by mouth (PO) daily from Cycle 1 Day 1 until the end of Cycle 12. Each cycle is 28 days. Re-treatment: -Pirtobrutinib 200 mg PO daily continuously

DRUGObinutuzumab

Obinutuzumab is given intravenously from Cycle 7 to Cycle 12, for total 6 cycles during initial treatment only. Initial treatment: \- Obinutuzumab intravenous (IV) following the standard schedule from Cycle 6 through Cycle 12 (total 6 cycles: 100 mg on Cycle 6 Day 1, 900 mg on Cycle 6 Day 2, 1000 mg on Cycle 6 Day 8 and Cycle 6 Day 15, 1000 mg on Day 1 of Cycle 7 through Cycle 12).


Locations(4)

New England Cancer Specialists

Scarborough, Maine, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT06333262


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