RecruitingPhase 2NCT06839053

Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma

SONIC: Escalated Inpatient Ramp-Up of Sonrotoclax in Patients With Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Mantle Cell Lymphoma (MCL) (SONIC Study)


Sponsor

Fred Hutchinson Cancer Center

Enrollment

30 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies the side effects of an escalated ramp-up of sonrotoclax following initial debulking with zanubrutinib or rituximab in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) that is newly diagnosed, has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Rituximab is a monoclonal antibody that binds to a protein called CD20, which is found on B-cells, and may kill tumor cells. Zanubrutinib may stop the growth of tumor cells by blocking a protein called Bruton's tyrosine kinase (BTK), which is needed for tumor cell growth. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (BCL-2). This protein helps certain types of blood tumor cells to survive and grow. When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and helps them die. Giving an increased dose of sonrotoclax over a shorter period of time in combination with zanubrutinib or rituximab may be safe and tolerable in treating patients with newly diagnosed, relapsed or refractory CLL, SLL, and MCL.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — sonrotoclax, rituximab, and zanubrutinib — for people with certain types of blood cancers, including chronic lymphocytic leukemia (CLL) and other B-cell lymphomas. These drugs work by blocking signals that help cancer cells survive. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with CLL, small lymphocytic lymphoma (SLL), mantle cell lymphoma, or other specified B-cell cancers - Depending on the study group, you may be newly diagnosed or have received prior treatment - You have adequate organ function and general health **You may NOT be eligible if...** - You have certain other active cancers - You have uncontrolled infections or serious medical conditions - You have previously received specific drugs that may interact with the study treatment - You are pregnant or breastfeeding 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

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREGastrointestinal Endoscopy

Undergo endoscopy

BIOLOGICALRituximab

Given IV

DRUGSonrotoclax

Given PO

DRUGZanubrutinib

Given orally (PO)


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT06839053


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