NCT02204722

A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients

A Phase IV Study to Evaluate Efficacy and Safety of Imatinib(Glinib®) 600mg/Day Depending on Early Molecular Response in Newly Diagnosed Patients With Chronic Myeloid Leukemia in Chronic Phase

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate efficacy and safety of Imatinib in two groups of patients; all patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic phase. The group A, the reference group, will have 10% or less than 10% of the BCR-ABL level after three month dosing and be maintained their dose of 400mg/day. On the other hand, the group B, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day. The superiority of the group B will be proved by evaluating the MMR rate of these two groups after 12 months of administeration of Imatinib.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	600mg/day of Imatinib
DRUG	400mg/day of Imatinib

Timeline

• Start date: 2014-10-13
• Primary completion: 2017-05-23
• Completion: 2018-01-09
• First posted: 2014-07-30
• Last updated: 2018-06-15

Locations

1 site across 1 country: South Korea