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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

Must not have

Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort

Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of first dose of ixazomib through 30 days after the last dose of ixazomib was administered, up to 140 weeks.

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken specific strong medications or St. John's wort in the last 14 days.

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I have severe nerve damage in my hands or feet, or moderate with pain.

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I have mostly recovered from side effects of my last chemotherapy.

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I do not have any uncontrolled heart problems.

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I do not have an active infection, hepatitis B or C, or HIV.

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I am not pregnant or breastfeeding.

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I have not had major surgery in the last 2 weeks.

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I have a stomach or intestine condition that affects my ability to take pills.

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I have been treated with or been part of a study involving proteasome inhibitors.

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My cancer has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of first dose of ixazomib through 30 days after the last dose of ixazomib was administered, up to 140 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time of first dose of ixazomib through 30 days after the last dose of ixazomib was administered, up to 140 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time of first dose of ixazomib through 30 days after the last dose of ixazomib was administered, up to 140 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Remission Rate at 16 Weeks

Secondary study objectives

Overall Response Rate at 16 Weeks

Progression Free Survival (PFS) and Overall Survival (OS)

Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56

Other study objectives

Biomarkers of response to treatment

Mechanisms of resistance

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Rituximab

FDA approved

Ixazomib

FDA approved

0 / 15Eligibility criteria met