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Proteasome Inhibitor
Ixazomib + Rituximab for Non-Hodgkin Lymphoma
Phase 2
Waitlist Available
Led By Ajay K. Gopal
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have measurable disease defined by at least one of the following criteria: Lesions greater than 1.5 cm that can be accurately measured in two dimensions by computed tomography (CT) (preferred), or magnetic resonance imaging (MRI), and are not included in any prior field of radiation given to treat B-NHL; In patients with CLL, circulating lymphocytes >= 5,000 / mm^3; In patients with WM/LPL, measurable serum monoclonal immunoglobulin M (IgM)
Disease: FL; Criteria for diagnosis: histopathologic confirmation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests ixazomib citrate + rituximab to treat patients with slow-growing B-cell non-Hodgkin lymphoma.
Who is the study for?
This trial is for adults with certain slow-growing B-cell non-Hodgkin lymphomas, who haven't had specific treatments before. Participants must be able to consent, have adequate organ function, and if of childbearing potential, agree to use effective contraception or practice abstinence. They should not have active infections or other serious health issues that could affect the study.Check my eligibility
What is being tested?
The trial tests ixazomib citrate combined with rituximab against indolent B-cell non-Hodgkin lymphoma. Ixazomib may block enzymes needed for cancer cell growth while rituximab might prevent cancer spread by targeting specific cells.See study design
What are the potential side effects?
Potential side effects include allergic reactions to medication components, nerve damage (neuropathy), digestive problems that could interfere with drug absorption, blood disorders like low platelet counts or neutrophils, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor larger than 1.5 cm, high lymphocyte count, or measurable IgM in my blood.
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My diagnosis of follicular lymphoma was confirmed through tissue examination.
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My condition is Waldenstrom macroglobulinemia/Lymphoplasmacytic lymphoma, diagnosed according to WHO standards.
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My condition is Marginal Zone Lymphoma, confirmed by tissue analysis.
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My CLL/SLL diagnosis was confirmed through lab tests.
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I can take care of myself and perform daily activities.
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My platelet count is sufficient without recent transfusions.
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My condition is confirmed Mantle Cell Lymphoma through tissue examination.
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My kidneys are functioning well enough to clear waste.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ORR (CR + very good PR + PR + minor response) in patients with Waldenstrom macroglobulinemia (WM)/ lymphoplasmacytic lymphoma (LPL)
Overall response rate (ORR) (complete response [CR] + partial response [PR]) in patients with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)
Secondary outcome measures
CR rate
Duration of response (DOR)
Incidence of adverse events (AEs)
+3 moreOther outcome measures
Gene expression profiling on tumor specimens
Identification of clinical features (i.e. Mantle Cell International Prognostic score, Follicular Lymphoma International Prognostic Index score, and International Prognostic Scoring System score) and biomarker expression levels
Single nucleotide profile (SNP) genotyping for PSMB1 P11A
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ixazomib citrate, rituximab)Experimental Treatment3 Interventions
Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Ixazomib Citrate
2012
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,318 Total Patients Enrolled
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,881 Total Patients Enrolled
Ajay K. GopalPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
69 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your total bilirubin level is not more than 1.5 times the upper limit of the normal range.I have a tumor larger than 1.5 cm, high lymphocyte count, or measurable IgM in my blood.I haven't needed antibiotics for an infection in the last 14 days.I do not have an ongoing infection, hepatitis B or C, or HIV.You are allergic to ixazomib or any of its ingredients.I have moderate to severe nerve damage in my hands or feet, or mild with pain.My diagnosis of follicular lymphoma was confirmed through tissue examination.I agree to use effective contraception or practice abstinence during and for 90 days after the study.I have been diagnosed with a specific type of blood cancer and have not received standard treatment for it.My condition is Waldenstrom macroglobulinemia/Lymphoplasmacytic lymphoma, diagnosed according to WHO standards.My B-NHL condition requires treatment according to NCCN guidelines.I have not had major surgery in the last 2 weeks.I haven't taken specific strong medications or herbal supplements recently.I have not been in another drug study within the last 3 weeks.I have not had radiation, non-standard treatments, or antibiotics for my B-NHL within the last 21 days.My condition is Marginal Zone Lymphoma, confirmed by tissue analysis.I am a woman who cannot become pregnant or will use two birth control methods during the study.My white blood cell count is sufficient, or low due to my lymphoma.I have a stomach or intestine condition that affects my ability to take pills.I haven't had cancer treatment within the last 2 years, except for non-melanoma skin cancer or carcinoma in situ that was fully removed.Your levels of ALT and AST in your blood are not more than three times the normal limit.My CLL/SLL diagnosis was confirmed through lab tests.I can take care of myself and perform daily activities.My platelet count is sufficient without recent transfusions.My cancer has spread to my brain or spinal cord.My condition is confirmed Mantle Cell Lymphoma through tissue examination.My kidneys are functioning well enough to clear waste.I do not have uncontrolled heart problems or recent heart attacks.I am not pregnant or breastfeeding.My doctor does not believe my cancer is about to cause organ failure.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ixazomib citrate, rituximab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still unfilled positions in this clinical research program?
"Per the listing on clinicaltrials.gov, this particular trial is not currently recruiting patients for participation. The study was originally posted on 5/19/2016 and last updated on 10/19/2022. However, there are 2431 other trials that are actively recruiting patients at this time."
Answered by AI
How many individuals are taking part in this research project?
"This study is no longer recruiting patients. According to the latest update on October 19th, 2022, this trial is completed. If you are looking for other similar studies, there are currently 1945 trials for waldenstrom macroglobulinemia and 486 studies involving Rituximab that are actively searching for participants."
Answered by AI
Are there long-term risks associated with Rituximab?
"While there is some data supporting Rituximab's safety, it only exists in preclinical studies. Therefore, it received a score of 2."
Answered by AI
What are some common illnesses that Rituximab helps to alleviate?
"Rituximab offers a treatment solution for patients suffering from diffuse large b-cell lymphoma (dlbcl), b-cell lymphomas, and polyangium."
Answered by AI
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