NCT04416451

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will help researchers understand how effective the combination of venetoclax and rituximab is in treating MZL in people who have not received a previous treatment for their cancer.

Conditions

• Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	Induction:Rituximab will be administered per institutional guidelines once per week for 4 weeks at a dose of 375 mg/m\^2. Maintenance: In addition, patients will receive rituximab 375 mg/m2 starting on day 1 of the maintenance phase and repeated once every 3 months for 12 months (for a total of 4 infusions). On days when venetoclax and rituximab will both be administered, patients will take venetoclax prior to administration of rituximab.
DRUG	Venetoclax	Induction: Starting one week after the last induction dose of rituximab (approximately week 5), venetoclax will be administered orally at a flat dose of 100 mg daily and escalating each week to a target dose of 800 mg daily on the following schedule: * Week 1: 100 mg * Week 2: 200 mg * Week 3: 400 mg * Week 4: 800 mg Maintenance: Following the 4-week induction phase ramp-up of venetoclax, patients will begin their target dose of 800 mg venetoclax daily and continue this dose during the 24- month maintenance treatment phase. On days when venetoclax and rituximab will both be administered, patients will take venetoclax prior to administration of rituximab.

Timeline

• Start date: 2021-05-04
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2020-06-04
• Last updated: 2025-07-02

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study