A Clinical Study to Evaluate Efficacy and Safety of Imatinib (Glinib®) in Pateitns with Leukiemia
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0002068
- Lead Sponsor
- Dong-A ST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MMR rate at 12 months in two groups will be compared. Group A is consisted of patients with equal or less than 10% of BDR-ABL, Group B is consisted of patients with more than 10% of BDR-ABL.
- Secondary Outcome Measures
Name Time Method CCyR in group A and B;MMR in group A and B;CMR in group A and B;Sruvival rate in group A and B;Progression rate to AP/BC in group A and B;The Actual Administration