SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03232307

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase II Study of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL)

The goal of this clinical research study is to learn if a combination of ibrutinib, rituximab, and lenalidomide can help control newly diagnosed mantle cell lymphoma (MCL) in patients over 65. The safety of this drug combination will also be studied.

NCT03232307 Hematopoietic/Lymphoid Cancer Mantle Cell Lymphoma
MeSH: Lymphoma Lymphoma, Mantle-Cell
HPO: Lymphoma

4 Interventions

Name: Ibrutinib

Description: Orally at 560 mg daily for 28 days (one cycle) up to Cycle 11. Starting at Cycle 12, a 2 month supply of ibrutinib dispensed every other cycle. After 3 years, patients treated with ibrutinib in continuous cycles until progression of disease or unacceptable toxicity.

Type: Drug

Ibrutinib + Rituximab + Lenalidomide

Name: Rituximab

Description: 375 mg/m^2 intravenous infusion (IV) given on Days 1, 8, 15 and 22 for Cycles 1 and 2. Then, Day 1 of every cycle, for Cycles 3 - 8. Following Cycle 8 Rituximab given on Day 1 of every other cycle for up to 2 years.

Type: Drug

Ibrutinib + Rituximab + Lenalidomide

Name: Lenalidomide

Description: Orally at 20 mg daily on Days 1 - 21 of each 28 day cycle for up to one year.

Type: Drug

Ibrutinib + Rituximab + Lenalidomide

Name: Dexamethasone Sodium Sulfate

Description: Orally 40 mg weekly administered only for the first 2 cycles.

Type: Drug

Ibrutinib + Rituximab + Lenalidomide


Primary Outcomes

Description: Response assessed according to the International Workshop Standardization Response Criteria for Non-Hodgkin's Lymphoma (Cheson, 2014)

Measure: Overall Response Rate (ORR) at 4 Months of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL)

Time: 4 months

Secondary Outcomes

Description: Adverse events assessed according to the Common Toxicity Criteria for Adverse Events version 4.03. (CTCAE v4.03)

Measure: Summary of Adverse Events of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL)

Time: After 1 cycle, 28 days

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P4503A

Requires treatment with strong Cytochrome P4503A (CYP3A) inhibitors. --- P4503A ---



HPO Nodes


HPO:
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