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In this study, the efficacy and safety of two radotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib | Active Comparator | Imatinib 400mg QD |
|
| Radotinib 600mg | Experimental | Radotinib 300mg BID |
|
| Radotinib 800mg | Experimental | Radotinib 400mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib | Drug | 400mg/Tab, QD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major Molecular Response(MMR) by 12 months | Rate of Major Molecular Response (MMR) at Any Time within 12 months. MMR by 12 months will be assessed as responder if the patient has response at any time within 12 months. A major molecular response rate is defined as the ratio (%) of BCR-ABL/ABL ≤ 0.1% by international scale or a 3-log reduction in BCR-ABL transcript level from standardized baseline, as measured by standardized RQ-PCR assay. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete cytogenetic response (CCyR) by 12 months | Complete cytogenetic response is defined as complete disappearance of Philadelphia-positive in at least 20 metaphases examined. Chromosome analysis performed on less than 20 metaphases will not be accepted for this study | 12 months |
| Rate of complete molecular response (CMR) by 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| IL-YANG PHARM | IL-YANG Pharmaceutical. Co., LTD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Jakarta | Indonesia | ||||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28939746 | Derived | Kwak JY, Kim SH, Oh SJ, Zang DY, Kim H, Kim JA, Do YR, Kim HJ, Park JS, Choi CW, Lee WS, Mun YC, Kong JH, Chung JS, Shin HJ, Kim DY, Park J, Jung CW, Bunworasate U, Comia NS, Jootar S, Reksodiputro AH, Caguioa PB, Lee SE, Kim DW. Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia. Clin Cancer Res. 2017 Dec 1;23(23):7180-7188. doi: 10.1158/1078-0432.CCR-17-0957. Epub 2017 Sep 22. |
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| Radotinib | Drug | 100mg or 200mg/Capsule, 300mg or 400mg BID |
|
|
Complete molecular response is defined as negative BCR-ABL transcript levels, as measured twice by the internationally standardized RQ-PCR assay. The rate of complete molecular response by cycle 12 is defined as an at least 4.5 log reduction in BCR-ABL transcript levels from standardized baseline or BCR-ABL/ABL % ≤ 0.005% by the international scale. |
| 12 months |
| Rate of major molecular response (MMR) at 12 months | Rate of Major Molecular response will be assessed at 12 months at that timepoint. Number of Participants With Major Molecular Response (MMR) at 12 months. | 12 month |
| Rate of subjects with disease progression | Disease progression by month 12 will be compared between each groups. | 12 months |
| Batangas |
| Philippines |
| Local Institution | Manila | Philippines |
| Local Institution | Busan | 602-715 | South Korea |
| Local Institution | Busan | 602-739 | South Korea |
| Local Institution | Busan | 633-165 | South Korea |
| Local Institution | Daegu | 700-712 | South Korea |
| Local Institution | Daejeon | 301-721 | South Korea |
| Local Institution | Gyeonggi-do | 431-070 | South Korea |
| Local Institution | Gyeonggi-do | 442-723 | South Korea |
| Local Institution | Gyeonggi-do | 443-721 | South Korea |
| Local Institution | Incheon | 405-760 | South Korea |
| Local Institution | Jeollabuk-do | 561-712 | South Korea |
| Local Institution | Jeonnam | 519-763 | South Korea |
| Local Institution | Seoul | 110-746 | South Korea |
| Local Institution | Seoul | 137-701 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Seoul | 152-703 | South Korea |
| Local Institution | Seoul | 158-710 | South Korea |
| Local Institution | Ulsan | 682-714 | South Korea |
| Local Institution | Wŏnju | 220-701 | South Korea |
| Local Institution | Bangkok | Thailand |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D007951 | Leukemia, Myeloid |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D010677 | Philadelphia Chromosome |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014178 | Translocation, Genetic |
| D002869 | Chromosome Aberrations |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| C000606751 | 4-methyl-N-(3-(4-methylimidazol-1-yl)-5-trifluoromethylphenyl)-3-(4-pyrazin-2-ylpyrimidin-2-ylamino)benzamide |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | 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 |
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