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Report for Clinical Trial NCT01503502

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II Study of Flumatinib Versus Imatinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

It is an open-label, randomized, multi-center study. The efficacy and safety of two flumatinib doses, 400 mg once daily and 600 mg once daily, will be compared with imatinib 400 mg once daily in newly diagnosed (within 6 months) patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

NCT01503502 Myelogenous Leukemia, Chronic
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome
HPO:Chronic myelogenous leukemia Leukemia Myeloid leukemia

2 Interventions

Name: flumatinib

Description: Flumatinib was supplied as 100 and 200 mg film-coated tablets for oral administration. Storage condition: 25°C, light proof, sealed.
Type: Drug
Group Labels: 2

flumatinib 400mg qd flumatinib 600 mg qd

Name: imatinib

Description: Imatinib was supplied as 100 mg film-coated tablets. Storage condition: 25°C (77°F). Protected from moisture.
Type: Drug
Group Labels: 1

imatinib


Primary Outcomes

Description: Obtain major molecular response (MMR) rate at 6 months in newly diagnosed Ph+ CML patients through comparison of the efficacy results of flumatinib with that of imtinib.

Measure: To compare the rate of MMR at 6 months

Time: 6 months

Secondary Outcomes

Measure: To compare the rate of MMR at 12 months

Time: 12 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T315I

Exclusion Criteria: 1. Previously documented T315I mutations. --- T315I ---



HPO Nodes


HPO: