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

NCT04212013 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-07-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Ariela Noy, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2027-03-18
Completion
2027-03-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04212013 on ClinicalTrials.gov