Status:
TERMINATED
A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients
Lead Sponsor:
Dong-A ST Co., Ltd.
Collaborating Sponsors:
SeoulCRO
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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, th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2018
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT02204722
Start Date
October 13 2014
End Date
January 9 2018
Last Update
June 15 2018
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138736