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Aurora Kinase Inhibitor

Triple Therapy for Lymphoma

Phase 1

Waitlist Available

Led By Catherine S Diefenbach

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (obtained within 30 days of registration)

Patients must have histologically confirmed relapsed or refractory mantle cell lymphoma or low grade B-cell non-Hodgkin lymphoma (NHL); patients with evidence of transformation to a high grade histology will not be eligible

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237, bortezomib or rituximab

Administration of pancreatic enzymes is not permitted at any time while on study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 8 (course 1)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of two drugs, alisertib and bortezomib, when given together with rituximab to treat patients with mantle cell lymphoma or B-cell low grade non-Hodgkin lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory).

Who is the study for?

This trial is for adults with relapsed or refractory mantle cell lymphoma or low grade B-cell non-Hodgkin lymphoma. Participants must have adequate organ function, no high-grade cancer transformation, and agree to use contraception. They should not have had certain treatments recently and must be able to take oral medication.

What is being tested?

The trial tests the combination of alisertib and bortezomib with rituximab to find the best dose and side effects profile in treating specific types of lymphoma that are resistant or have returned after treatment. It aims to see if this combo can better inhibit cancer cell growth.

What are the potential side effects?

Potential side effects include reactions related to immune system interference by rituximab, as well as possible organ inflammation, fatigue, digestive issues from alisertib and bortezomib. Side effects vary based on individual tolerance.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

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My lymphoma has come back or hasn't responded to treatment, but it hasn't become more aggressive.

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I have HIV but no AIDS, a low viral load, and not on certain HIV meds.

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I can take care of myself but may not be able to do heavy physical work.

Exclusion Criteria

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

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I have had allergic reactions to medications similar to MLN8237, bortezomib, or rituximab.

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I am not taking pancreatic enzymes while on this study.

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I do not have brain metastases.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have conditions like severe sleep apnea or COPD that cause extreme daytime sleepiness.

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I cannot swallow pills or follow the required fasting for medication.

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I am HIV-positive but not on certain HIV medications, and my CD4 count is above 300.

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I am not taking certain seizure medications, rifampin, or St. John's wort.

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I have stopped using proton pump inhibitors for at least 4 days.

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I am not pregnant and will stop breastfeeding to participate.

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I experience significant numbness or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 8 (course 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 8 (course 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 8 (course 1) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Recommended phase II dose of alisertib when combined with bortezomib and rituximab, defined as the highest dose level at which < 33% of the dose cohort experience a dose limiting toxicity (DLT)

Recommended phase II dose of bortezomib when combined with alisertib and rituximab, defined as the highest dose level at which < 33% of the dose cohort experience a dose limiting toxicity (DLT)

Secondary study objectives

Duration of response (DOR)

Overall response rate (ORR) (complete response and partial response)

Progression free survival (PFS)

Other study objectives

Aurora A expression measured from patient biopsy specimens

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 (alisertib, bortezomib, and rituximab)Experimental Treatment4 Interventions

Patients receive alisertib PO BID on days 1-7; bortezomib SC on days 1, 8, and 15; and rituximab IV on day 1. Treatment repeats every 28 days\* in the absence of disease progression or unacceptable toxicity. Note: \*After 8 courses, treatment with rituximab repeats once every 3 courses (12 weeks) in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Alisertib

2010

Completed Phase 2

~1260