SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01131325

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Multi-center, Single Arm Study of Nilotinib in Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Patients With Low Imatinib Trough Plasma Concentrations

This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.

NCT01131325 CML Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels
MeSH: Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome
HPO: Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: nilotinib

Description: All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours

Type: Drug

Nilotinib


Primary Outcomes

Measure: To determine the number of ELN-guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations (<850 ng/mL) treated with nilotinib.

Time: up to 2 years

Secondary Outcomes

Measure: To determine the proportion of ELN-defined optimal responses on nilotinib.

Time: up to 2 years

Measure: To determine the rate and time to loss of CCyR, MMR and CMR on nilotinib.

Time: up to 2 years

Measure: To determine the time to and duration of the CCyR, MMR and CMR achieved on nilotinib.

Time: up to 2 years

Measure: To determine EFS, PFS and OS with up to 2 years of nilotinib treatment and overall safety profile

Time: up to 2 years

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T315I

Inclusion Criteria: - Ph+ CML-CP within 12 months of diagnosis - Imatinib 400 mg qd for up to 12 months - Imatinib trough plasma concentration <850 ng/mL - Patient that have met response milestones including: 1. CHR and at least minor CyR (Ph+ ≤65%) at 3 months from diagnosis 2. At least pCyR at 6 months from diagnosis (Ph+ ≤35%) 3. CCyR at 12 months from diagnosis Exclusion Criteria: - Prior documented failure events including: - Loss of CHR or CCyR - Less than CHR (stable disease or disease progression) at 3 months after diagnosis - No CyR at 6 months after diagnosis - Less than PCyR at 12 months after diagnosis - Prior accelerated phase or blast phase CML - Previously documented T315I mutation - Previous treatment with any other tyrosine kinase inhibitor except for imatinib. --- T315I ---

- Treatment with other investigational agents within 30 days of Day 1. Inclusion Criteria: - Ph+ CML-CP within 12 months of diagnosis - Imatinib 400 mg qd for up to 12 months - Imatinib trough plasma concentration <850 ng/mL - Patient that have met response milestones including: 1. CHR and at least minor CyR (Ph+ ≤65%) at 3 months from diagnosis 2. At least pCyR at 6 months from diagnosis (Ph+ ≤35%) 3. CCyR at 12 months from diagnosis Exclusion Criteria: - Prior documented failure events including: - Loss of CHR or CCyR - Less than CHR (stable disease or disease progression) at 3 months after diagnosis - No CyR at 6 months after diagnosis - Less than PCyR at 12 months after diagnosis - Prior accelerated phase or blast phase CML - Previously documented T315I mutation - Previous treatment with any other tyrosine kinase inhibitor except for imatinib. --- 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