Not provided
Not provided
Not provided
Not provided
Sponsor's decision to halt the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| SeoulCRO | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 600mg/day of Imatinib | Drug |
| ||
| 400mg/day of Imatinib |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyu-Hyoung Lee, M.D. | Asan Medical Center | Principal Investigator |
| Jin-hee Park, M.D. | Gachon University Gil Medical Center | Principal Investigator |
| Chul-won Choi, M.D. | Korea University Guro Hospital | Principal Investigator |
| Sae-ryun Lee, M.D. | Korea University Ansan Hospital | Principal Investigator |
| Yong Park, M.D. | Korea University Anam Hospital | Principal Investigator |
| Joo-sup Joeng, M.D. | Pusan National University Hospital | Principal Investigator |
| Jung-ok Lee, M.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Chul-won Jung, M.D. | Seoul Medical Center | Principal Investigator |
| Sung-soo Yoon, M.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138736 | South Korea |
Not provided
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Kyung-ha Kim, M.D. |
| Soonchunhyang University Hospital Seoul |
| Principal Investigator |
| Joon-sung Park, M.D. | Ajou University School of Medicine | Principal Investigator |
| Duk-yeon Cho, M.D. | Chungnam National University Hospital | Principal Investigator |
| Sung-nam Im, M.D. | Inje University Haeundae Paik Hospital | Principal Investigator |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |