Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients

• Imatinib (Drug), also known as Glivec, Gleevec: 400mg/Tab, QD
• Radotinib (Drug), also known as IY5511HCl: 100mg or 200mg/Capsule, 300mg or 400mg BID

Primary outcomes

• Rate of Major Molecular Response(MMR) by 12 months [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.

Secondary outcomes

• Rate of complete cytogenetic response (CCyR) by 12 months [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
• Rate of complete molecular response (CMR) by 12 months [12 months]: 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.
• Rate of major molecular response (MMR) at 12 months [12 month]: 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.
• Rate of subjects with disease progression [12 months]: Disease progression by month 12 will be compared between each groups.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients with confirmed diagnosis of chronic phase CML within last 3 months
* Patients with cytogenetically confirmed Ph positive CML in early chronic phase

Exclusion Criteria:

* Patients with Philadelphia chromosome negative but BCR-ABL positive CML
* Patients who used imatinib for 8 days or longer before study entry
* Patients who had been treated with other targeted anti-cancer therapy, except for Hydrea or Agrylin, which inhibits the growth of leukemic cells
* Patients with impaired cardiac function
* Cytologically confirmed CNS involvement
* Severe or uncontrolled chronic medical condition
* Other significant congenital or acquired bleeding disorders that are not related to underlying leukemia
* Patients who had a major surgery within 4 weeks prior to study entry or has not recovered from side effects of such surgery

• Results publication: 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. PMID 28939746

• IL-YANG PHARM, Study director, IL-YANG Pharmaceutical. Co., LTD