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Ixazomib + Rituximab for Mantle Cell Lymphoma

Phase 1 & 2

Waitlist Available

Led By Jonathon Cohen, MD, MS

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Are surgically sterile, OR

- t(11;14) detected by fluorescence in situ hybridization (FISH), conventional cytogenetics, or other molecular evaluation

Must not have

Infection requiring intravenous antibiotic therapy or other serious infection within 14 days before study enrollment.

Female patients who are lactating or have a positive serum pregnancy test during the screening period.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing ixazomib given with rituximab after stem cell transplant to see how well it works and what the side effects are.

Who is the study for?

This trial is for patients with Mantle Cell Lymphoma in remission after a stem cell transplant. They must have good organ function, no recent chemotherapy or radiation, and no uncontrolled illnesses. Women should not be pregnant and participants must agree to use effective contraception.

What is being tested?

The trial tests the combination of Ixazomib (an enzyme blocker) and Rituximab (a monoclonal antibody) post-stem cell transplant to prevent cancer recurrence. It aims to determine the best dose of Ixazomib while assessing how well both drugs work together.

What are the potential side effects?

Potential side effects include reactions related to immune system activation by Rituximab, such as fever or chills, and effects from Ixazomib like gastrointestinal issues or skin rash. Organ inflammation and blood disorders may also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am surgically sterile.

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My cancer has a specific genetic feature known as t(11;14).

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I have been postmenopausal for at least one year.

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My kidneys are functioning well enough, with a creatinine clearance rate of at least 30 mL/min.

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My cancer cells show cyclin D1 presence.

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I completed a stem cell transplant after my first cancer treatment without relapsing before the transplant.

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My diagnosis of mantle cell lymphoma has been confirmed.

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My condition hasn't worsened since my transplant.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I haven't needed IV antibiotics or had a serious infection in the last 14 days.

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I am not pregnant or breastfeeding.

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

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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 not had major surgery in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Progression-free survival (PFS), defined as the percentage of patients who have received at least one dose of study therapy who are alive and free of disease progression or relapse at 1-year post autologous stem cell transplant (Phase II)

Secondary study objectives

Incidence of adverse events graded according to CTCAE version 4.03 (Phase I & II)

Median OS (Phase II)

Median PFS (Phase II)

+3 more

Other study objectives

Median OS for patients who have a pre-transplant PET/CT (Phase II)

Median PFS for patients who have a pre-transplant PET/CT (Phase II)

PFS for patients who have a pre-transplant PET/CT (Phase II)

+1 more

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 Treatment2 Interventions

Beginning between 70-180 days after stem cell transplant, patients receive ixazomib PO on days 1, 8, and 15, and rituximab IV (or SC after first dose if deemed appropriate) on day 1 of courses 1, 3, 5, 7, and 9. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

FDA approved

Ixazomib

FDA approved

0 / 14Eligibility criteria met