Clinical trial NCT01511289: Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Bone Marrow Diseases
Hematologic Diseases
Keywords: Radotinib
CML-CP
Chronic Myeloid Leukemia, chronic phase
Lead sponsor: Il-Yang Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Major Molecular Response(MMR) by 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Rate of complete cytogenetic response (CCyR) by 12 months
timeFrame: 12 months
measure: Rate of complete molecular response (CMR) by 12 months
timeFrame: 12 months
measure: Rate of major molecular response (MMR) at 12 months
timeFrame: 12 month
measure: Rate of subjects with disease progression
timeFrame: 12 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Daejeon
country: Korea, Republic of
facility: Local Institution
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Incheon
country: Korea, Republic of
facility: Local Institution
city: Jeollabuk-do
country: Korea, Republic of
facility: Local Institution
city: Jeonnam
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Ulsan
country: Korea, Republic of
facility: Local Institution
city: Wonju
country: Korea, Republic of
facility: Local Institution
city: Batangas
country: Philippines
facility: Local Institution
city: Manilla
country: Philippines
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
Study officials:
affiliation: IL-YANG Pharmaceutical. Co., LTD
name: IL-YANG PHARM
role: STUDY_DIRECTOR
References:
citation: 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.