SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02339922

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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
MeSH: Lymphoma Lymphoma, Follicular Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Lymphoma, B-Cell, Marginal Zone Waldenstrom Macroglobulinemia
HPO: Chronic lymphatic leukemia Lymphoid leukemia Lymphoma Monoclonal immunoglobulin M proteinemia

3 Interventions

Name: Ixazomib Citrate

Description: Given PO

Type: Drug

Treatment (ixazomib citrate, rituximab)

Name: Laboratory Biomarker Analysis

Description: Correlative studies

Type: Other

Treatment (ixazomib citrate, rituximab)

Name: Rituximab

Description: Given IV

Type: Biological

Treatment (ixazomib citrate, rituximab)


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

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P11A

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 ---



HPO Nodes


HPO:
Chronic lymphatic leukemia
Genes 8
SAMHD1 RNASEH2B ADAR RNASEH2A IFIH1 RNASEH2C TREX1 PIK3R1
Lymphoid leukemia
Lymphoma
Genes 94
BLM MYC CDKN2A KRAS MYD88 RMRP RAG1 RAG2 MALT1 MSH6 RASGRP1 LIG4 TCF4 PMS2 ICOS NRAS WAS WIPF1 CD19 MS4A1 USB1 IGH TINF2 RB1 DCLRE1C TNFSF12 RTEL1 CTC1 CD27 CD28 PIK3R1 PRF1 NTHL1 TP63 POLE HLA-DRB1 NFKB1 NFKB2 RECQL4 RAD54B CHEK2 TNFRSF13C APC MLH1 TNFRSF13B DKC1 BIRC3 XIAP CASP10 NBN PRKCD COL14A1 FOXP1 CD81 PARN NOP10 CCND1 BCL10 BCL2 MSH2 CHD7 CTLA4 ATM BCL6 MAGT1 RUNX1 TNFRSF1B XRCC4 WRAP53 PTEN MDM2 FAS NHP2 ADA FASLG CR2 SH2D1A TERC AAGAB KIT TERT NSUN2 IL2RG LYST RNF43 ZAP70 DNASE1L3 TP53 RAD54L ITK STAT3 IL7R KIF11 PNP
Monoclonal immunoglobulin M proteinemia
Genes 1
MYD88