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

Phase 3

Completed

• Conditions: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome; Bone Marrow Diseases; Hematologic Diseases
• Interventions: Drug: Imatinib; Drug: Radotinib

• Registration Number: NCT01511289
• Lead Sponsor: Il-Yang Pharm. Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-18
• Primary Completion: 2015-02
• Status Verified: 2016-01
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imatinib	Imatinib	Imatinib 400mg QD
Radotinib 600mg	Radotinib	Radotinib 300mg BID
Radotinib 800mg	Radotinib	Radotinib 400mg BID

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 subjects with disease progression	12 months	Disease progression by month 12 will be compared between each groups.

Trial Locations

Locations (1)

Local Institution; 🇹🇭 Bangkok, Thailand