KCT0002068
Recruiting
未知
A Phase IV Study to Evaluate Efficacy and Safety of Imatinib (Glinib®)600mg/day Depending on Early Molecular Responses in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase
Dong-A ST0 sites150 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Sponsor
- Dong-A ST
- Enrollment
- 150
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Not specified
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