A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Myeloid Leukemia

Intervention / Treatment
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* Drug: 600mg/day of Imatinib
* Drug: 400mg/day of Imatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B<br>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. | Drug: 600mg/day of Imatinib<br> <br> |
| Experimental: Group A<br>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. | Drug: 400mg/day of Imatinib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMR rate at 12 months in two groups | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CCyR in group A and B | CCyR rate for 12 months and the duration of the complete CCyR will be evaluated. | 12 months | 
| MMR in group A and B | MMR rate for 12 months and the duration of MMR will be measured. | 12 months | 
| CMR in group A and B |  | 12 months | 
| Survival rate in group A and B |  | 12 months | 
| Progression rate to AP/BC in group A and B |  | 12 months | 
| the actual administration | the total dose will be divided by total days of the treatment. | 12 months |