NCT06849713

Zanubrutinib, Obinutuzumab, and Sonrotoclax in Previously Untreated Patients With CLL or SLL

A Phase 2 Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the proportion of participants who achieve undetectable measurable residual disease (uMRD) in previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Detailed description

This is a multicenter phase II study evaluating zanubrutinib, obinutuzumab, and sonrotoclax in previously untreated patients with CLL or SLL. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved sonrotoclax as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved zanubrutinib and obinutuzumab as a treatment option for your disease. The combination of zanubrutinib, obinutuzumab, and sonrotoclax (BOSon regimen) is not an approved regimen for CLL or SLL and is investigational in this study. The duration of the protocol therapy will depend on participant's individual response, with a longer course of therapy for participants with a lower response, and a shorter course of therapy for those with a faster response. After removal from the protocol therapy, participants will be followed for up to 2 years after the final patient is enrolled. It is expected that about 40 people will take part in this research study.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma (SLL)

Interventions

Type	Name	Description
DRUG	Zanubrutinib	Bruton's Tyrosine Kinase (BTK) inhibitor
DRUG	Sonrotoclax	B-cell lymphoma 2 (BCL2) protein inhibitor
DRUG	Obinutuzumab	Anti-CD20 monoclonal antibody

Timeline

• Start date: 2025-05-16
• Primary completion: 2028-03-01
• Completion: 2030-03-01
• First posted: 2025-02-27
• Last updated: 2025-09-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study