Ixazomib + Rituximab for Non-Hodgkin Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen by Ajay K. Gopal

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Washington

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well ixazomib citrate and rituximab work in treating patients with B-cell non-Hodgkin lymphoma that grows slowly (indolent). Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving ixazomib citrate together with rituximab may work better in treating indolent B-cell non-Hodgkin lymphoma.

Research Team

Ajay K. Gopal

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

This trial is for adults with certain slow-growing B-cell non-Hodgkin lymphomas, who haven't had specific treatments before. Participants must be able to consent, have adequate organ function, and if of childbearing potential, agree to use effective contraception or practice abstinence. They should not have active infections or other serious health issues that could affect the study.

Inclusion Criteria

Your total bilirubin level is not more than 1.5 times the upper limit of the normal range.

Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

I have a tumor larger than 1.5 cm, high lymphocyte count, or measurable IgM in my blood.

Exclusion Criteria

I haven't needed antibiotics for an infection in the last 14 days.

I do not have an ongoing infection, hepatitis B or C, or HIV.

Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol

Treatment Details

Interventions

• Ixazomib Citrate (Proteasome Inhibitor)
• Rituximab (Monoclonal Antibodies)

Trial Overview The trial tests ixazomib citrate combined with rituximab against indolent B-cell non-Hodgkin lymphoma. Ixazomib may block enzymes needed for cancer cell growth while rituximab might prevent cancer spread by targeting specific cells.

Participant Groups

Group I: Treatment (ixazomib citrate, rituximab) Experimental Treatment 3 Interventions

Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity.

Ixazomib Citrate is already approved in Canada, Japan for the following indications:

Approved in Canada as Ninlaro for:

• Multiple myeloma

Approved in Japan as Ninlaro for:

• Multiple myeloma

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Dr. Timothy H. Dellit

University of Washington

Chief Executive Officer since 2023

MD from University of Washington

Dr. Anneliese Schleyer

University of Washington

Chief Medical Officer since 2023

MD, MHA

Millennium Pharmaceuticals, Inc.

Industry Sponsor

Trials

406

Recruited

46,900+

Dr. Christophe Bianchi

Millennium Pharmaceuticals, Inc.

Chief Medical Officer since 2006

MD from University of Geneva

Dr. Deborah Dunsire

Millennium Pharmaceuticals, Inc.

Chief Executive Officer since 2005

MD from University of Witwatersrand