Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphosarcoma

Follicular Lymphoma

Marginal Zone Lymphoma

Indolent B Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Amino Acids

Zanubrutinib

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Rituximab (Standard of Care) will be administered for up to 6 cycles (28-day cycles).

Cycle 1: Days 1, 8, 15, and 22. Cycle 2-6: Day 1, every 28 days.

Rituximab: Intravenous rituximab formulations (IV rituximab or IV rituximab biosimilars will be administered by IV infusion at a dose of 375 mg/m2 per local institutional guidelines) or subcutaneous rituximab formulations (RITUXAN HYCELA) 1,400 mg/23,400 Units (1,400 mg rituximab and 23,400 Units hyaluronidase human) subcutaneously at a fixed dose per local institutional guidelines.

Zanubrutinib 320 mg will be administered orally once daily starting on day 1 of cycle 1.

Zanubrutinib will be continued once daily for up to 24 cycles or until disease progression or unacceptable toxicity occurs.

Zanubrutinib is an anti-cancer medication administered orally.

Rituximab is a biologic medication administered intravenously or subcutaneously.

Richard Corona

Sameh Gaballa, MD

The purpose of the study is to establish the safety and efficacy of zanubrutinib in combination with rituximab for people with untreated B-cell lymphomas (marginal zone lymphoma and follicular lymphomas).

Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas

A Phase 2 Open-Label, Multicenter Study of Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas

Overall response rate will be determined using a 5 point scale per the Lugano criteria.

Time to event endpoints (Progression free survival, Overall survival, duration of response, time to next anti-lymphoma therapy) will be summarized by Kaplan-Meier method for each cohort.

Safety and tolerability of the combination use of zanubrutinib and rituximab will be summarized descriptively by frequencies and percentages. Statistics will be given on type, severity, frequency, and attribution of adverse events.

BeiGene, Ltd.

H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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