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

Il-Yang Pharm. Co., Ltd.242 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

242

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Local Institution

Jakarta, Indonesia

Local Institution

Batangas, Philippines

Local Institution

Manila, Philippines

Local Institution

Busan, South Korea

Local Institution

Busan, South Korea

Local Institution

Busan, South Korea

Local Institution

Daegu, South Korea

Local Institution

Daejeon, South Korea

Local Institution

Gyeonggi-do, South Korea

Local Institution

Gyeonggi-do, South Korea

...and 12 more locations

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

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.

Time frame: 12 months

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.

Time frame: 12 month

Rate of subjects with disease progression

Disease progression by month 12 will be compared between each groups.

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (22)

Outcomes

Primary Outcomes

Secondary Outcomes