A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma
Gottfried von Keudell, MD PhD
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)
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, P…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically confirmed Marginal Zone Lymphoma * Patients must have measurable disease as defined by at least one lymph node ≥1.5 cm or spleen \> 13 cm * Patients with intestinal MALT lymphoma must have disease that is detectable by EGD or colonoscopy with biopsy * Patients with gastric MALT lymphoma must be h. pylori negative. Patients who are h. pylori positive are allowed if they have failed a trial of h. pylori eradication * Patients with gastric MALT lymphoma who are h. pylori negative or who relapsed/refractory disease after h. pylori eradic…
Interventions
- DrugVenetoclax
B-cell lymphoma inhibitor, tablets taken orally per protocol.
- DrugRituximab
Anti-CD20 monoclonal antibody, 10mL or 50 mL single-use vials, via intravenous (into the vein) infusion per protocol.
Location
- Beth Israel Deaconess Medical CenterBoston, Massachusetts