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Proteasome Inhibitor
Ixazomib + Rituximab for Mantle Cell Lymphoma
Phase 2
Waitlist Available
Led By Hun J Lee
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2
Patients must have relapsed and/or refractory disease to at least 2 lines of therapy including either an anthracycline- or bendamustine- based regimen and a BTK inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start date of treatment to death date, assessed up to 1 year
Awards & highlights
Study Summary
This trial is testing a combination of ixazomib and rituximab to see if it's more effective than rituximab alone in treating mantle cell lymphoma.
Who is the study for?
This trial is for adults with mantle cell lymphoma that's returned or isn't responding to BTK inhibitors. They need measurable disease, decent organ function (specific blood counts and liver/kidney tests), and a performance status of 0-2, indicating they can care for themselves. Women must not be pregnant and agree to contraception; men also need to use birth control.Check my eligibility
What is being tested?
The study is testing the combination of ixazomib, an enzyme blocker that may stop cancer growth, with rituximab, an immunotherapy drug that might prevent tumor cells from growing. The goal is to see if this combo works better than rituximab alone in patients who've had at least two prior treatments including chemotherapy and a BTK inhibitor.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, infections due to weakened immune systems, heart issues like uncontrolled hypertension or arrhythmias, gastrointestinal problems affecting drug absorption or tolerance, nerve damage causing pain or numbness (peripheral neuropathy), and general fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
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My condition didn't improve after at least 2 treatments, including anthracycline or bendamustine and a BTK inhibitor.
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I am a male and agree to use effective contraception during and up to 90 days after the study.
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My diagnosis is mantle cell lymphoma confirmed by tissue analysis.
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I have a visible tumor, enlarged spleen, or cancer in my bone marrow.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start date of treatment to death date, assessed up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start date of treatment to death date, assessed up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete remission rate of BTK inhibitor refractory mantle cell lymphoma patients with ixazomib and rituximab
Secondary outcome measures
Incidence of toxicities
Overall response rate
Overall survival (OS)
+1 moreOther outcome measures
Biomarkers of response to treatment
Mechanisms of resistance
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ixazomib, rituximab)Experimental Treatment3 Interventions
Patients receive ixazomib by mouth on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV over 4-8 hours on days 1, 8, 15, and 22 of cycle 1. Beginning in cycle 3, patients receive rituximab Intravenous over 4-8 hours on day 1. Treatment repeats every 28 days up to cycle 12 in the absence of disease progression or unacceptable toxicity. Patients benefiting from treatment may continue to receive ixazomib indefinitely in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
FDA approved
Ixazomib
FDA approved
Rituximab
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,778 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,643 Total Patients Enrolled
Hun J LeePrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken specific strong medications or St. John's wort in the last 14 days.I am able to care for myself and perform daily activities.My condition didn't improve after at least 2 treatments, including anthracycline or bendamustine and a BTK inhibitor.I am a male and agree to use effective contraception during and up to 90 days after the study.I haven't had radiotherapy in the last 14 days, or if it was a small area, in the last 7 days.I have severe nerve damage in my hands or feet, or moderate with pain.I have mostly recovered from side effects of my last chemotherapy.I had an infection treated with antibiotics within the last 14 days but am cleared by a specialist.I do not have any uncontrolled heart problems.I do not have an active infection, hepatitis B or C, or HIV.I don't have any serious health or mental conditions that could stop me from completing the treatment.I am a woman who is either postmenopausal, surgically sterile, or willing to use two forms of birth control.I haven't had any cancer besides nonmelanoma skin cancer or carcinoma in situ, or if I have, it was more than 2 years ago and fully treated.I am not pregnant or breastfeeding.I have not had major surgery in the last 2 weeks.I have a stomach or intestine condition that affects my ability to take pills.My diagnosis is mantle cell lymphoma confirmed by tissue analysis.I have a visible tumor, enlarged spleen, or cancer in my bone marrow.You are allergic to any of the medications used in the study or any of the substances used to make them.I have been treated with or been part of a study involving proteasome inhibitors.My cancer has spread to my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ixazomib, rituximab)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Has Ixazomib received authorization from the FDA?
"Our team has assigned Ixazomib a safety rating of 2, as Phase 2 trials have not yet yielded efficacy data but there is evidence supporting the compound's security."
Answered by AI
What is the upper threshold of participants for this research endeavor?
"Affirmative. According to clinicaltrials.gov, this medical experiment is recruiting participants since its launch on August 28th 2019 and has been updated as recent as January 31st 2020. The trial needs 24 individuals to be enrolled across 1 site."
Answered by AI
What health ailments is Ixazomib typically prescribed for?
"Ixazomib has been found to be a reliable intervention for diffuse large b-cell lymphoma (dlbcl). It can also help manage other conditions such as polyangium, pemphigus vulgaris, and various types of B-cell lymphomas."
Answered by AI
Are there any opportunities to take part in this experiment at the moment?
"The clinical trial is still recruiting participants, as the information on the site demonstrates. This medical study was initially posted in August of 2019 and was refreshed at the end of January 2020."
Answered by AI
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