SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02422719

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Radotinib Efficacy and Safety Validation in Chronic Phase Chronic Myeloid Leukemia Patients Who Are Intolerant or Resistant to at Least Two Tyrosine Kinase Inhibitors As a Third or Subsequent Line Therapy

The purpose of this study is to determine whether radotinib is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors.

NCT02422719 Chronic Myeloid Leukemia
MeSH: Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase
HPO: Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: Radotinib

Description: Radotinib 400mg bid

Type: Drug

Radotinib


Primary Outcomes

Description: The rate of achieving major cytogenetic response [35% or less t(9;22) chromosome by conventional banding technique] in bone marrow by 12 months after radotinib treatment will be the primary end point.

Measure: Rate of Major cytogenetic response

Time: by 12 months after radotinib treatment

Secondary Outcomes

Measure: Rate of Major Molecular response (MR3.0) on each time point

Time: up to 12 months

Measure: The number of Participants with Adverse Events

Time: 12 months

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T315I

Exclusion Criteria: - T315I mutation - Prior exposure to radotinib - Accelerated or blastic phase - galactose intolerance, severe lactase deficiency or glucose galactose malabsorption - Prior history of intensive cytotoxic chemotherapy except for TKIs - Significant cardiac problem - QTcF > 450 msec - Pancreatitis history prior to study enrollment - Clinically significant malignant disease other than CML - Pregnant or breast feeding woman Inclusion Criteria: - Chronic myeloid leukemia chronic phase (CP-CML) patients who are not tolerable or resistant to prior 2 or more tyrosine kinase inhibitors (TKIs). --- T315I ---

Exclusion Criteria: - T315I mutation - Prior exposure to radotinib - Accelerated or blastic phase - galactose intolerance, severe lactase deficiency or glucose galactose malabsorption - Prior history of intensive cytotoxic chemotherapy except for TKIs - Significant cardiac problem - QTcF > 450 msec - Pancreatitis history prior to study enrollment - Clinically significant malignant disease other than CML - Pregnant or breast feeding woman Chronic Myeloid Leukemia Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase The purpose of this study is to determine whether radotinib 400mg bid is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors. --- T315I ---



HPO Nodes


HPO:
Chronic myelogenous leukemia
Genes 5
MPL BCR JAK2 KIT THPO
Leukemia
Genes 125
MPL RNASEH2B KRAS NPM1 TET2 MYD88 TSR2 RPL26 RPL27 TREX1 EFL1 PIGL SCN11A FLT3 PMS2 RPL35A EVC2 ABL1 CEBPA RARA NRAS WAS WIPF1 ATRX SH2B3 PDGFRA RB1 RNASEH2A PDGFRB CALR ARHGAP26 SH3GL1 RPS7 RPS10 NUMA1 GATA1 GATA2 RPS15A APC NSD1 ETV6 TCIRG1 DNAJC21 EVC SRP54 RPS17 NBN RPS19 SAMHD1 MSH2 RPS24 NUP214 RPS26 RPS27 RPS28 RPS29 MLLT10 RUNX1 XRCC4 CBFB CBL BCR ADAR TRIP13 ADA2 NSUN2 CREBBP PICALM GFI1 F13A1 F13B FANCA FANCC BLM FANCD2 FANCE NUTM1 JAK2 IFIH1 TYROBP MSH6 FANCG LIG4 PTPN11 SAMD9L THPO NF1 STS PIGA BRCA2 DYNC2LI1 PIK3CA SBDS GLI1 PIK3R1 BRD4 SETBP1 RNASEH2C LPP BUB1 BUB1B SCN9A SCN10A TREM2 MLF1 MLH1 ELANE DKC1 ATM HAX1 RPL35 GNB1 BUB3 CEP57 TAL1 KIT TAL2 RPL5 EP300 TP53 RPL11 KIF11 RPL15 DNMT3A RPL18
Myeloid leukemia
Genes 12
GATA2 F13A1 CBL ARHGAP26 F13B KRAS PTPN11 SAMD9L KIT SETBP1 NF1 NRAS