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NOT YET RECRUITING
NCT07550855
PHASE2

Sonrotoclax, Zanubrutinib and Rituximab in Previously Untreated Patients With Follicular Lymphoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

Follicular lymphoma (FL) remains an incurable indolent B-cell lymphoma for many patients, and although rituximab-based chemoimmunotherapy can achieve high initial response rates, a substantial proportion of patients experience early progression, including POD24, which is associated with poor long-term outcomes. This underscores the need for more effective and better-tolerated frontline treatment strategies, particularly chemotherapy-free approaches. The present study is based on a strong biologic rationale that simultaneously targets two key pathogenic mechanisms in FL: aberrant B-cell receptor signaling and impaired apoptosis driven by BCL2 overexpression. Zanubrutinib, a next-generation BTK inhibitor, has shown clinical activity with a favorable safety profile in FL, while sonrotoclax, a potent and highly selective next-generation BCL2 inhibitor, has demonstrated promising preclinical and early clinical activity. In combination with rituximab, this chemotherapy-free triplet regimen may produce deeper and more durable remissions while maintaining manageable toxicity, and therefore has the potential to expand frontline treatment options and improve outcomes for patients with previously untreated FL.

Official title: A Phase II, Multicenter, Single-Arm Study of Sonrotoclax, Zanubrutinib and Rituximab in Previously Untreated Patients With Follicular Lymphoma (FLOURISH)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-09-01

Completion Date

2029-09-30

Last Updated

2026-04-24

Healthy Volunteers

No

Interventions

DRUG

Sotoclax in combination with zanubrutinib and rituximab regimen

Zanubrutinib oral administration, Sotoclax oral administration, Rituximab intravenous injection.

Locations (1)

Sun Yat-sen Universitiy Cancer Center

Guangzhou, Guangdong, China