← Back to Search

Kinase Inhibitor

Ibrutinib + Rituximab for Marginal Zone Lymphoma

Phase 3
Waitlist Available
Led By Ariela Noy, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 12 months (females) and 90 days (males) after the last dose of study drug
Histologically documented marginal zone lymphoma, including splenic, nodal, and extranodal sub-types at the enrolling institution
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months after randomization
Awards & highlights

Study Summary

This trial will test a new treatment for people with a certain type of lymphoma who haven't been treated before. It will compare a new combination drug to a similar combination with a placebo to see which is more effective.

Who is the study for?
This trial is for adults with untreated marginal zone lymphoma, including splenic, nodal, and extranodal types. They must have a life expectancy over 3 months and be able to perform daily activities with slight limitations (ECOG ≤2). Women of childbearing potential need a negative pregnancy test and agree to use birth control. Participants should not have severe heart conditions, bleeding disorders, central nervous system lymphoma or other serious health issues that could affect the study.Check my eligibility
What is being tested?
The study tests if rituximab combined with ibrutinib is more effective than rituximab with a placebo in treating marginal zone lymphoma. Patients are randomly assigned to either the drug combo or the placebo group to compare outcomes.See study design
What are the potential side effects?
Possible side effects include digestive issues, increased risk of infections due to weakened immune response, fatigue, muscle and bone pain. Ibrutinib may also cause irregular heartbeat or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree to use effective birth control during and after the study.
Select...
My lymphoma type is confirmed as marginal zone lymphoma.
Select...
I have gastric MALT lymphoma, am H. pylori negative or didn't respond to treatment, and can't or won't have gastric radiation.
Select...
I need treatment for my condition due to serious symptoms or risk to my organs.
Select...
I have MZL and only had antibiotics for infections or antiviral therapy for HCV before.
Select...
I have a tumor larger than 1.5 cm or significant spleen enlargement.
Select...
I am a woman who cannot become pregnant or I have a negative pregnancy test.
Select...
I am 18 years old or older.
Select...
My stomach lymphoma is not caused by H. pylori or treatments for it didn't work.
Select...
I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
complete response

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038
4%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ibrutinib/RituximabExperimental Treatment2 Interventions
All subjects meeting eligibility criteria will receive rituximab: 375 mg/m^2 on days 1, 8, 15 and 22 on cycle 1.
Group II: Ibrutinib/PlaceboPlacebo Group2 Interventions
Ibrutinib capsules (140 mg each) will be dosed at 560 mg once daily on a 28-day cycle on a continuous basis. Placebo capsules will be similarly dosed at 4 capsules daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Ibrutinib
2014
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,785 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,797 Total Patients Enrolled
Ariela Noy, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
105 Total Patients Enrolled

Media Library

Ibrutinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04212013 — Phase 3
Marginal Zone Lymphoma Research Study Groups: Ibrutinib/Rituximab, Ibrutinib/Placebo
Marginal Zone Lymphoma Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT04212013 — Phase 3
Ibrutinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04212013 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any dangers associated with Rituximab treatments?

"There is both prior clinical data and multiple rounds of supportive data for Rituximab's safety, so it received a score of 3."

Answered by AI

Are there any current vacancies for participants in this trial?

"The study is seeking participants and was last updated on March 9th, 2022. The original posting date was December 23rd, 2019 according to information available on clinicaltrials.gov"

Answered by AI

What are some maladies that Rituximab has been shown to improve?

"Rituximab can be used to treat several types of cancer, including diffuse large b-cell lymphoma (dlbcl), b-cell lymphomas, and polyangium."

Answered by AI

How many people will be given this medication as part of the research study?

"One hundred and thirty-eight individuals who fit the bill are needed for this experiment. Patients have the choice of participating from multiple locations, such as Mayo Clinic Cancer Center in Rochester, Minnesota or Moffitt Cancer Center in Tampa, Florida."

Answered by AI

What is the existing research on Rituximab?

"Rituximab was first trialled in 1993 at the National Institutes of Health Clinical Center. In the nearly three decades since, there have been over 19000 completed clinical trials worldwide. 537 of these trials are still active, with a significant portion taking place in Rochester, Minnesota."

Answered by AI

In how many different areas is this trial being run today?

"There are 26 locations for this study, 13 of which are actively recruiting patients. These include Mayo Clinic Cancer Center in Rochester, Moffitt Cancer Center in Tampa, and Northwestern Medicine (Robert H Lurie Cancer Center) in Chicago."

Answered by AI
~1 spots leftby Jun 2024