NCT06510309

Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma

A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Gottfried von Keudell, MD PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the combination of rituximab and venetoclax is effective in treating participants with untreated Marginal Zone Lymphoma (MZL). The names of the study drugs involved in this study are: * Venetoclax (a type of inhibitor) * Rituximab (a type of antibody)

Detailed description

This is a phase II study of rituximab plus venetoclax in participants with MZL who have not had prior chemotherapy. The purpose of this study is to see if the combination of rituximab and venetoclax is effective in treating Marginal Zone Lymphoma. The U.S. Food and Drug Administration (FDA) has not approved venetoclax for MZL but it has been approved for other uses. The FDA has approved rituximab as a treatment option for MZL. The research study procedures include screening for eligibility, study treatment visits, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, blood tests, bone marrow and tumor biopsies, and electrocardiograms. Participants will receive study treatment for up to 24 months and will be followed for 1 year after discontinuation of the study drugs. It is expected that about 33 people will take part in this research study. Abbvie, Inc. is funding this research study by providing venetoclax.

Conditions

• Lymphoma
• Marginal Zone Lymphoma
• MZL

Interventions

Type	Name	Description
DRUG	Venetoclax	B-cell lymphoma inhibitor, tablets taken orally per protocol.
DRUG	Rituximab	Anti-CD20 monoclonal antibody, 10mL or 50 mL single-use vials, via intravenous (into the vein) infusion per protocol.

Timeline

• Start date: 2026-02-11
• Primary completion: 2028-10-01
• Completion: 2031-10-01
• First posted: 2024-07-19
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study