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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511289
• Other study ID #: IY5511A3001
• Status: Completed
• Phase: Phase 3
• First received: January 3, 2012
• Last updated: February 22, 2016
• Start date: August 2011

Study information

• Verified date: January 2016
• Source: Il-Yang Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety (MFDS)Indonesia: National Agency of Drug and Food ControlPhilippines: Bureau of Food and DrugsThailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Hematologic Diseases
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Philadelphia Chromosome

Intervention

Drug:
• Imatinib
400mg/Tab, QD
• Radotinib
100mg or 200mg/Capsule, 300mg or 400mg BID

Locations

Country	Name	City	State
Indonesia	Local Institution	Jakarta
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Daegu
Korea, Republic of	Local Institution	Daejeon
Korea, Republic of	Local Institution	Gyeonggi-do
Korea, Republic of	Local Institution	Gyeonggi-do
Korea, Republic of	Local Institution	Gyeonggi-do
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Jeollabuk-do
Korea, Republic of	Local Institution	Jeonnam
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Ulsan
Korea, Republic of	Local Institution	Wonju
Philippines	Local Institution	Batangas
Philippines	Local Institution	Manilla
Thailand	Local Institution	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Il-Yang Pharm. Co., Ltd.

Countries where clinical trial is conducted

Indonesia,  Korea, Republic of,  Philippines,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Rate of complete molecular response (CMR) by 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.	12 months	No
Secondary	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	No
Secondary	Rate of subjects with disease progression	Disease progression by month 12 will be compared between each groups.	12 months	No