Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether radotinib is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors.
The purpose of this study is to determine whether radotinib 400mg bid is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors. The primary end point is major cytogenetic response by 12 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radotinib | Experimental | Radotinib treatement single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radotinib | Drug | Radotinib 400mg bid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major cytogenetic response | The rate of achieving major cytogenetic response [35% or less t(9;22) chromosome by conventional banding technique] in bone marrow by 12 months after radotinib treatment will be the primary end point. | by 12 months after radotinib treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major Molecular response (MR3.0) on each time point | up to 12 months | |
| The number of Participants with Adverse Events | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hae Kyung Shin, R.N. | Contact | +82-52-230-1418 | gem9771uuh@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Hawk Kim, M.D., Ph.D. | Ulsan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulsan University Hospital | Recruiting | Ulsan | 682714 | 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 |
|---|---|
| C000606751 | 4-methyl-N-(3-(4-methylimidazol-1-yl)-5-trifluoromethylphenyl)-3-(4-pyrazin-2-ylpyrimidin-2-ylamino)benzamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |