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Ibrutinib + Rituximab for Marginal Zone Lymphoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038Trial Design
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Who is running the clinical trial?
Media Library
- I have been screened for hepatitis B and C, and if positive for HBV, I am on appropriate treatment.I have no cancer history except for certain skin cancers or cancers treated over 2 years ago with no current signs.I agree to use effective birth control during and after the study.I have lymphoma in my brain or spinal cord.My lymphoma type is confirmed as marginal zone lymphoma.I have gastric MALT lymphoma, am H. pylori negative or didn't respond to treatment, and can't or won't have gastric radiation.I have another cancer, but it won't affect this cancer treatment's safety or results.I need treatment for my condition due to serious symptoms or risk to my organs.I haven't taken strong immune system suppressants or more than 20 mg/day of prednisone in the last 28 days.I have MZL and only had antibiotics for infections or antiviral therapy for HCV before.I have a tumor larger than 1.5 cm or significant spleen enlargement.I do not have serious heart problems or recent heart attacks.I am a woman who cannot become pregnant or I have a negative pregnancy test.I am 18 years old or older.I haven't taken strong CYP3A inhibitors in the last 7 days nor do I need them continuously.My stomach lymphoma is not caused by H. pylori or treatments for it didn't work.I do not have any ongoing infections that aren’t under control.I can take care of myself but might not be able to do heavy physical work.I have a bleeding disorder such as von Willebrand's disease or hemophilia.I finished treatment for an infection less than 14 days ago.
- Group 1: Ibrutinib/Rituximab
- Group 2: Ibrutinib/Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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"
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."
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."
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."
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