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

Il-Yang Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Philadelphia Chromosome; Bone Marrow Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia; Leukemia, Myeloid; Hematologic Diseases

Treatments: Drug: Radotinib; Drug: Imatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01511289

IY5511A3001

Details and patient eligibility

About

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).

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 3 patient groups

Imatinib

Active Comparator group

Description:

Imatinib 400mg QD

Treatment:

Drug: Imatinib

Radotinib 600mg

Experimental group

Description:

Radotinib 300mg BID

Treatment:

Drug: Radotinib

Radotinib 800mg

Experimental group

Description:

Radotinib 400mg BID

Treatment:

Drug: Radotinib