SNPMiner Trials by Shray Alag


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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 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 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

Secondary 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 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

Measure: 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 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

Other 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 years

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


HPO Nodes


Chronic lymphatic leukemia
Genes 8
ADAR TREX1 IFIH1 PIK3R1 RNASEH2A SAMHD1 RNASEH2B RNASEH2C
Monoclonal immunoglobulin M proteinemia
Genes 2
MYD88 MYD88
Lymphoma
Genes 133
ATM KRAS CD19 IGH DDX41 BCL10 BIRC3 FOXP1 MS4A1 TP63 RAG1 LIG4 NFKB2 MSH6 TERC RECQL4 NTHL1 WIPF1 CTC1 LYST NOP10 RASGRP1 TNFRSF1B XRCC4 PRKCD NHP2 MAGT1 TNFRSF13B IGH RMRP RUNX1 CTLA4 DCLRE1C FAS ICOS RNF43 NSUN2 XIAP IL7R CASP10 BCL6 CDKN2A ATM IL2RG RTEL1 PARN NBN KIT TNFRSF13C TCF4 ICOS TNFSF12 CHEK2 USB1 CD19 CR2 NRAS MSH2 WAS BCL10 CASP10 MYD88 COL14A1 PRKCD TNFRSF13B MYC MDM2 SH2D1A CCND1 BCL10 CFTR CD27 PGM3 TCF4 CHD7 IGH LIG4 BLM BCL2 TET2 HLA-DRB1 PRSS1 NPM1 KIF11 ITK WRAP53 RAD54B TINF2 FAS DKC1 APC CD81 LIG4 BLM CD28 DKC1 AAGAB RAG2 TNFRSF1B MLH1 TNFRSF13C DNASE1L3 NFKB1 PMS2 ASXL1 IL2RG PRF1 PTEN MALT1 RAD54L CTLA4 CD28 PNP SRSF2 TNFSF12 STAT3 POLE ADA CR2 ADA FASLG PIK3R1 TP53 CTRC ZAP70 MYD88 RB1 RMRP SPINK1 TERT KLHDC8B NBN RHOH