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

Sponsor

Il-Yang Pharm. Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01511289

Collaborator

(none)

242

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Bone Marrow Diseases Hematologic Diseases	Drug: Imatinib Drug: Radotinib	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

242 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Imatinib Imatinib 400mg QD	Drug: Imatinib 400mg/Tab, QD Other Names: Glivec Gleevec
Experimental: Radotinib 600mg Radotinib 300mg BID	Drug: Radotinib 100mg or 200mg/Capsule, 300mg or 400mg BID Other Names: IY5511HCl
Experimental: Radotinib 800mg Radotinib 400mg BID	Drug: Radotinib 100mg or 200mg/Capsule, 300mg or 400mg BID Other Names: IY5511HCl

Arm

Intervention/Treatment

Active Comparator: Imatinib

Imatinib 400mg QD

Drug: Imatinib

400mg/Tab, QD

Other Names:

Glivec

Gleevec

Experimental: Radotinib 600mg

Radotinib 300mg BID

Drug: Radotinib

100mg or 200mg/Capsule, 300mg or 400mg BID

Other Names:

IY5511HCl

Experimental: Radotinib 800mg

Radotinib 400mg BID

Drug: Radotinib

100mg or 200mg/Capsule, 300mg or 400mg BID

Other Names:

IY5511HCl

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Local Institution	Jakarta	Indonesia
2	Local Institution	Busan	Korea, Republic of	602-715
3	Local Institution	Busan	Korea, Republic of	602-739
4	Local Institution	Busan	Korea, Republic of	633-165
5	Local Institution	Daegu	Korea, Republic of	700-712
6	Local Institution	Daejeon	Korea, Republic of	301-721
7	Local Institution	Gyeonggi-do	Korea, Republic of	431-070
8	Local Institution	Gyeonggi-do	Korea, Republic of	442-723
9	Local Institution	Gyeonggi-do	Korea, Republic of	443-721
10	Local Institution	Incheon	Korea, Republic of	405-760
11	Local Institution	Jeollabuk-do	Korea, Republic of	561-712
12	Local Institution	Jeonnam	Korea, Republic of	519-763
13	Local Institution	Seoul	Korea, Republic of	110-746
14	Local Institution	Seoul	Korea, Republic of	137-701
15	Local Institution	Seoul	Korea, Republic of	138-736
16	Local Institution	Seoul	Korea, Republic of	152-703
17	Local Institution	Seoul	Korea, Republic of	158-710
18	Local Institution	Ulsan	Korea, Republic of	682-714
19	Local Institution	Wonju	Korea, Republic of	220-701
20	Local Institution	Batangas	Philippines
21	Local Institution	Manilla	Philippines
22	Local Institution	Bangkok	Thailand