Ibrutinib + Ixazomib for Waldenstrom's Macroglobulinemia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byAsher A. Chanan-Khan, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies the side effects of ibrutinib citrate when given with ixazomib, and determines how well they work in treating patients with Waldenstrom macroglobulinemia that is newly diagnosed, has come back (recurrent) or does not respond to treatment (refractory). Enzyme inhibitors, such as ibrutinib and ixazomib citrate, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

This trial is for adults with Waldenstrom macroglobulinemia, whether newly diagnosed, relapsed or treatment-resistant. Participants must be able to give consent, provide blood and bone marrow samples, have certain minimum blood counts and organ function levels, not be pregnant or breastfeeding, use effective contraception if of childbearing potential, and have no major surgery planned.

Inclusion Criteria

My condition is confirmed Waldenstrom macroglobulinemia, whether new, relapsed, or refractory.

I have signs of disease like specific proteins in my blood, swollen lymph nodes, or more than 10% of my bone marrow is affected.

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

+10 more

Exclusion Criteria

I do not have any uncontrolled heart or blood pressure problems.

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

I have an active hepatitis B or C infection, or I am HIV positive.

+17 more

Participant Groups

The study tests the effectiveness and side effects of combining two enzyme inhibitors: Ibrutinib citrate and Ixazomib citrate in treating Waldenstrom macroglobulinemia. It includes laboratory biomarker analysis along with pharmacodynamic and pharmacokinetic studies to understand how these drugs work together against cancer cells.

1Treatment groups

Experimental Treatment

Group I: Treatment (ixazomib citrate, ibrutinib)Experimental Treatment5 Interventions

Patients receive ixazomib citrate PO on days 1, 8, and 15 and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Imbruvica for: