Status:
COMPLETED
Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients
Lead Sponsor:
Il-Yang Pharm. Co., Ltd.
Conditions:
Leukemia
Leukemia, Myeloid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Patients with confirmed diagnosis of chronic phase CML within last 3 months
- Patients with cytogenetically confirmed Ph positive CML in early chronic phase
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT01511289
Start Date
August 1 2011
Last Update
February 24 2016
Active Locations (22)
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1
Local Institution
Jakarta, Indonesia
2
Local Institution
Batangas, Philippines
3
Local Institution
Manila, Philippines
4
Local Institution
Busan, South Korea, 602-715