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Report for Clinical Trial NCT01131325

Developed by Shray Alag, 2020.
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:Leuk 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
Group Labels: 1

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

Allocation: N/A

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: