A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- Registration Number
- NCT02204722
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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, 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 55
- 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 Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B 600mg/day of Imatinib 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 400mg/day of Imatinib 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.
- Primary Outcome Measures
Name Time Method MMR rate at 12 months in two groups 12 months 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 MMR in group A and B 12 months MMR rate for 12 months and the duration of MMR will be measured.
CMR in group A and B 12 months Survival rate in group A and B 12 months CCyR in group A and B 12 months CCyR rate for 12 months and the duration of the complete CCyR will be evaluated.
Progression rate to AP/BC in group A and B 12 months the actual administration 12 months the total dose will be divided by total days of the treatment.
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of