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.
OUTLINE: 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. After completion of study treatment, patients are followed up at 30 days and then every 3 months for 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL)
ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived.
Time frame: Up to 5 years
ORR (CR + Very Good PR + PR + Minor Response) in Patients With Waldenstrom Macroglobulinemia (WM)/ Lymphoplasmacytic Lymphoma (LPL)
ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived.
Time frame: Up to 5 years
Duration of Response (DOR)
DOR will be calculated to determine durability. Non-responders will be excluded from the analysis of DOR. Kaplan Meier methodology will be used to estimate event-free curves.
Time frame: From the time by which the measurement criteria are met for CR or PR, whichever is recorded first, until death or the first date by which recurrent or progressive disease is objectively documented, assessed up to 5 years
Progression-free Survival (PFS)
Data for subjects without disease progression or death will be censored at the date of the last tumor assessment. Kaplan-Meier methodology will be used to estimate the event-free curves.
Time frame: Time from the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years
Overall Survival
Time frame: Up to 5 years
CR Rate
Time frame: Up to 5 years
Time to Next Therapy (TNT)
Data for subjects that have not received additional anti-neoplastic therapy will be censored at the date of last known contact.
Time frame: From the time of first study drug administration until the date of subsequent the first subsequent therapy given to treat the B-NHL, assessed up to 5 years
Incidence of Adverse Events (AEs)
Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Safety summaries will include tabulations in the form of tables. The frequency of treatment-emergent AE's will be summarized. Additional AE summaries will include AE frequency by AE severity and relationship to the study drug. AE's requiring discontinuation of the study drug will be summarized separately, both overall and by AE severity and by relationship to the study drug. Clinically significant abnormal laboratory values will be summarized over study visits.
Time frame: Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months).
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