Ixazomib + Rituximab for Mantle Cell Lymphoma

Overseen By Hun J Lee

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Strong CYP3A inducers

Disqualifiers: Pregnancy, CNS involvement, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 48 weeks

3 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well ixazomib and rituximab work in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond (refractory) to BTK inhibitor treatment. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with rituximab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving ixazomib and rituximab may work better in treating patients with mantle cell lymphoma compared to rituximab alone.

Research Team

Hun Lee, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Creatinine clearance >= 30 mL/min

Platelets >= 50,000/mm^3

Total bilirubin < 1.5 x institutional upper limit of normal (ULN). In patients with documented Gilbert's syndrome, total bilirubin =< 2.5 x ULN

Exclusion Criteria

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

Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial

I haven't had radiotherapy in the last 14 days, or if it was a small area, in the last 7 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ixazomib orally on days 1, 8, and 15, and rituximab intravenously on days 1, 8, 15, and 22 of cycle 1. Treatment repeats every 28 days for up to 12 cycles.

48 weeks

12 cycles with multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Extension

Participants benefiting from treatment may continue to receive ixazomib indefinitely in the absence of disease progression or unacceptable toxicity.

Treatment Details

Interventions

• Ixazomib
• Rituximab

Trial Overview 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.

Participant Groups

Group I: Treatment (ixazomib, rituximab) Experimental Treatment 3 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.

Ixazomib is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Ninlaro for:

• Multiple myeloma in combination with lenalidomide and dexamethasone

Approved in European Union as Ninlaro for:

• Multiple myeloma in combination with lenalidomide and dexamethasone

Approved in Canada as Ninlaro for:

• Multiple myeloma in combination with lenalidomide and dexamethasone

Approved in Japan as Ninlaro for:

• Multiple myeloma in combination with lenalidomide and dexamethasone

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+