There is one clinical 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. 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.
Single nucleotide profile (SNP) genotyping for PSMB1 P11A. --- P11A ---
SNP genotyping for PSMB1 P11A will be performed and will be correlated with response to ixazomib citrate and ixazomib citrate plus rituximab.. Gene expression profiling on tumor specimens. --- P11A ---
Description: ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived.Measure: 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) Time: Up to 5 years
Description: ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived.Measure: ORR (CR + very good PR + PR + minor response) in patients with Waldenstrom macroglobulinemia (WM)/ lymphoplasmacytic lymphoma (LPL) Time: Up to 5 years
Description: 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.Measure: Duration of response (DOR) Time: 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
Description: 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.Measure: Progression-free survival (PFS) Time: Time from the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years
Description: Data for subjects that have not received additional anti-neoplastic therapy will be censored at the date of last known contact.Measure: Time to next therapy (TNT) Time: 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
Description: 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.Measure: Incidence of adverse events (AEs) Time: Up to 30 days after administration of the last dose of ixazomib citrate
Description: SNP genotyping for PSMB1 P11A will be performed and will be correlated with response to ixazomib citrate and ixazomib citrate plus rituximab.Measure: Single nucleotide profile (SNP) genotyping for PSMB1 P11A Time: Up to 5 years
Description: Will be correlated with response to rituximab.Measure: Gene expression profiling on tumor specimens Time: Up to 5 years
Description: Will be correlated with response to ixazomib citrate and ixazomib citrate plus rituximab.Measure: Tumor expression of cluster of differentiation 68, nuclear transcription factor kappa-B, p65, p27, and proteasome subunit, alpha-type, 5 by immunohistochemistry Time: Up to 5 years