SNPMiner Trials (Home Page)
Report for Mutation P11A
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Window Study of Ixazomib in Untreated Indolent B-NHL
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.
NCT02339922 Chronic Lymphocytic Leukemia Follicular Lymphoma Lymphoplasmacytic Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Small Lymphocytic Lymphoma Waldenstrom Macroglobulinemia Drug: Ixazomib Citrate Other: Laboratory Biomarker Analysis Biological: Rituximab MeSH:Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Lymphoma, B-Cell, Marginal Zone Waldenstrom Macroglobul Waldenstrom Macroglobulinemia
HPO:Chronic lymphatic leukemia Lymphoma Monoclonal immunoglobulin M proteinemia
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 ---
Primary Outcomes
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 yearsDescription: 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 yearsSecondary Outcomes
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 yearsDescription: 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 yearsMeasure: Overall survival Time: Up to 5 years
Measure: CR rate Time: 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 yearsDescription: 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 citrateOther Outcomes
Measure: Identification of clinical features (i.e. Mantle Cell International Prognostic score, Follicular Lymphoma International Prognostic Index score, and International Prognostic Scoring System score) and biomarker expression levels Time: Up to 5 yearsDescription: 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 yearsDescription: Will be correlated with response to rituximab.
Measure: Gene expression profiling on tumor specimens Time: Up to 5 yearsDescription: 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