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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

Must not have

Known ongoing or known active systemic infection, known active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive

Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

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

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

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

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

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I haven't taken specific strong medications or herbal supplements recently.

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

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My cancer has spread to my brain or spinal cord.

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I do not have uncontrolled heart problems or recent heart attacks.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

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 study objectives

Duration of response (DOR)

Incidence of adverse events (AEs)

Progression-free survival (PFS)

+1 more

Other study objectives

Gene expression profiling on tumor specimens

Single nucleotide profile (SNP) genotyping for PSMB1 P11A

Tumor expression of cluster of differentiation 68, nuclear transcription factor kappa-B, p65, p27, and proteasome subunit, alpha-type, 5 by immunohistochemistry

Awards & Highlights

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 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

~2990

Ixazomib Citrate

2012

Completed Phase 3

~970