Ixazomib + Rituximab for Mantle Cell Lymphoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByJonathon Cohen, MD, MS

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Emory University

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I/II trial studies the side effects and best dose of ixazomib citrate (ixazomib) when given together with rituximab and to see how well they work after stem cell transplant in treating patients with mantle cell lymphoma that are no longer showing signs or symptoms of cancer. Ixazomib may stop the growth of cancer cell by blocking enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving ixazomib together with rituximab after transplant may help prevent the cancer from coming back.

Eligibility Criteria

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.

Inclusion Criteria

I am surgically sterile.

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

I have been postmenopausal for at least one year.

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

My cancer cells show cyclin D1 presence.

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

My diagnosis of mantle cell lymphoma has been confirmed.

My condition hasn't worsened since my transplant.

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

Exclusion Criteria

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

I am not pregnant or breastfeeding.

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

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

I have not had major surgery in the last 14 days.

Participant Groups

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.

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.