Trial | NCT02204722  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    imatinib ...

  • Study Participants

    55
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.
Study Started
Oct 13
2014
Primary Completion
May 23
2017
Study Completion
Jan 09
2018
Last Update
Jun 15
2018

Drug 600mg/day of Imatinib

Drug 400mg/day of Imatinib

Group B Experimental

the group who has more than 10% of the BCR-ABL(IS) level for three months will receive 600mg/day of Imatinib after three months.

Group A Experimental

the group who has more than 10% of the BCR-ABL(IS) level for three months will maintain the dose, 400mg/day of Imatinib, after three months.

Criteria 

Inclusion Criteria:

at the age of 18 or more
newly diagnosed within three months as a Chronic Myeloid Leukemia
with positive Philadelphia chromosome and appearance of BCR-ABL transcript
with 0 - 2 of ECOG Performance Status
with normal renal function
with normal hepatic function
able to understand and decide to involve the study

Exclusion Criteria:

history of radiation therapy for more than 25% of bone marrow due to other malignant diseases
history of other clinically relevant malignant tumors
with bleeding disorders which are not related to leukemia
evidence of clinically relevant cardiac dysfunction
with severe disease which cannot be regulated by other organs
a previous administration of Imatinib more than a week prior to the first dose.
participation in other drug study(eg. intervention trial) within 30 days prior to the screening visit
HIV-infected
females with pregnancy, childbearing or lactating potential
other reasons determined by investigators
No Results Posted