Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients
A Phase 3 Multinational, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Ph+ CML Patients in Early Chronic Phase
1 other identifier
interventional
242
4 countries
22
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 leukemia
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 3, 2012
CompletedFirst Posted
Study publicly available on registry
January 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedFebruary 24, 2016
January 1, 2016
3.5 years
January 3, 2012
February 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Rate of complete cytogenetic response (CCyR) by 12 months
12 months
Rate of complete molecular response (CMR) by 12 months
12 months
Rate of major molecular response (MMR) at 12 months
12 month
Rate of subjects with disease progression
12 months
Study Arms (3)
Imatinib
ACTIVE COMPARATORImatinib 400mg QD
Radotinib 600mg
EXPERIMENTALRadotinib 300mg BID
Radotinib 800mg
EXPERIMENTALRadotinib 400mg BID
Interventions
Eligibility Criteria
You may qualify if:
- Patients with confirmed diagnosis of chronic phase CML within last 3 months
- Patients with cytogenetically confirmed Ph positive CML in early chronic phase
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Local Institution
Jakarta, Indonesia
Local Institution
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
Related Publications (1)
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: 28939746DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
IL-YANG PHARM
IL-YANG Pharmaceutical. Co., LTD
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2012
First Posted
January 18, 2012
Study Start
August 1, 2011
Primary Completion
February 1, 2015
Last Updated
February 24, 2016
Record last verified: 2016-01