Last updated on May 2019

Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma


Brief description of study

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. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ixazomib citrate together with rituximab may work better in treating indolent B-cell non-Hodgkin lymphoma.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To assess the efficacy of ixazomib (ixazomib citrate) as monotherapy in untreated indolent B-cell non-Hodgkin lymphoma (B-NHL) based on overall response rate.

SECONDARY OBJECTIVES:

I. To evaluate efficacy parameters including the duration of response (DOR), progression-free survival (PFS), time to next therapy (TNT), and complete response rate (CR) of ixazomib in untreated indolent B-NHL.

II. To evaluate the safety and tolerability of ixazomib in subjects with B-NHL.

III. To evaluate the safety and tolerability of ixazomib plus rituximab in subjects with B-NHL.

IV. To evaluate the efficacy parameters including overall response rate (ORR), DOR, TNT, PFS, and CR of the combination of rituximab with ixazomib.

TERTIARY/EXPLORATORY OBJECTIVES:

I. To evaluate clinical and biological prognostic and predictive biomarkers relative to treatment outcomes of ixazomib in indolent B-NHL.

OUTLINE

Patients receive ixazomib citrate orally (PO) once weekly every 4 weeks. Upon completion of 6 courses of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for 3 years.

Clinical Study Identifier: NCT02339922

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Recruitment Status: Open


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