NCT04212013

A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study of Ibrutinib in Combination With Rituximab in Subjects With Treatment Naïve Marginal Zone Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · 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 ibrutinib can help people with marginal zone lymphoma who have not received treatment in the past. The study will also compare the combination of rituximab and ibrutinib with the combination of rituximab and placebo to see which combination works better.

Conditions

• Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Ibrutinib capsules (140 mg each) will be dosed at 560 mg once daily on a 28-day cycle on a continuous basis.
DRUG	Rituximab	Will receive rituximab: 375 mg/m\^2 on days 1, 8, 15 and 22 of cycle 1
OTHER	Placebo	Placebo capsules will be similarly dosed at 4 capsules daily.

Timeline

• Start date: 2019-12-23
• Primary completion: 2027-03-18
• Completion: 2027-03-18
• First posted: 2019-12-26
• Last updated: 2025-07-23

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study