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

February 22, 2016 updated by: Il-Yang Pharm. Co., Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Local Institution
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Local Institution
      • Busan, Korea, Republic of, 602-715
        • Local Institution
      • Busan, Korea, Republic of, 633-165
        • Local Institution
      • Daegu, Korea, Republic of, 700-712
        • Local Institution
      • Daejeon, Korea, Republic of, 301-721
        • Local Institution
      • Gyeonggi-do, Korea, Republic of, 431-070
        • Local Institution
      • Gyeonggi-do, Korea, Republic of, 442-723
        • Local Institution
      • Gyeonggi-do, Korea, Republic of, 443-721
        • Local Institution
      • Incheon, Korea, Republic of, 405-760
        • Local Institution
      • Jeollabuk-do, Korea, Republic of, 561-712
        • Local Institution
      • Jeonnam, Korea, Republic of, 519-763
        • Local Institution
      • Seoul, Korea, Republic of, 138-736
        • Local Institution
      • Seoul, Korea, Republic of, 137-701
        • Local Institution
      • Seoul, Korea, Republic of, 152-703
        • Local Institution
      • Seoul, Korea, Republic of, 110-746
        • Local Institution
      • Seoul, Korea, Republic of, 158-710
        • Local Institution
      • Ulsan, Korea, Republic of, 682-714
        • Local Institution
      • Wonju, Korea, Republic of, 220-701
        • Local Institution
  • Philippines
      • Batangas, Philippines
        • Local Institution
      • Manilla, Philippines
        • Local Institution
  • Thailand
      • Bangkok, Thailand
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Imatinib
Imatinib 400mg QD
Drug: Imatinib
400mg/Tab, QD
Other Names:
  • Gleevec
  • Glivec
EXPERIMENTAL: Radotinib 600mg
Radotinib 300mg BID
Drug: Radotinib
100mg or 200mg/Capsule, 300mg or 400mg BID
Other Names:
  • IY5511HCl
EXPERIMENTAL: Radotinib 800mg
Radotinib 400mg BID
Drug: Radotinib
100mg or 200mg/Capsule, 300mg or 400mg BID
Other Names:
  • IY5511HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Major Molecular Response(MMR) by 12 months
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complete cytogenetic response (CCyR) by 12 months
Time Frame: 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
Rate of complete molecular response (CMR) by 12 months
Time Frame: 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
Rate of major molecular response (MMR) at 12 months
Time Frame: 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.
12 month
Rate of subjects with disease progression
Time Frame: 12 months
Disease progression by month 12 will be compared between each groups.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Il-Yang Pharm. Co., Ltd.

Investigators

  • Study Director: IL-YANG PHARM, IL-YANG Pharmaceutical. Co., LTD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

January 3, 2012

First Submitted That Met QC Criteria

January 12, 2012

First Posted (ESTIMATE)

January 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IY5511A3001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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