Chronic Myeloid Leukemia
Conditions
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.
Interventions
DRUG600mg/day of Imatinib
DRUG400mg/day of Imatinib
Sponsors
SeoulCRO
Dong-A ST Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
| Survival rate in group A and B | 12 months | — |
Countries
South Korea
Outcome results
None listed