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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Il-Yang Pharm. Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01511289
First received: January 3, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention Phase
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Bone Marrow Diseases
Hematologic Diseases
Drug: Imatinib
Drug: Radotinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Il-Yang Pharm. Co., Ltd.:

Primary Outcome Measures:
  • Rate of Major Molecular Response(MMR) by 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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:
  • Rate of complete cytogenetic response (CCyR) by 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 complete molecular response (CMR) by 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 major molecular response (MMR) at 12 months [ Time Frame: 12 month ] [ Designated as safety issue: No ]

    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 subjects with disease progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Disease progression by month 12 will be compared between each groups.


Estimated Enrollment: 240
Study Start Date: August 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Imatinib Drug: Imatinib
400mg/Tab, QD
Other Names:
  • Glivec
  • Gleevec
Experimental: Radotinib 300mg
Radotinib 300mg BID
Drug: Radotinib
100mg or 200mg/Capsule, 300mg or 400mg BID
Other Name: IY5511HCl
Experimental: Radotinib 400mg
Radotinib 400mg BID
Drug: Radotinib
100mg or 200mg/Capsule, 300mg or 400mg BID
Other Name: IY5511HCl

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511289

Contacts
Contact: IL-YANG PHARM 82 31 281 7851

Locations
Indonesia
Local Institution Recruiting
Jakarta, Indonesia
Korea, Republic of
Local Institution Recruiting
Busan, Korea, Republic of, 602-739
Local Institution Recruiting
Busan, Korea, Republic of, 602-715
Local Institution Recruiting
Busan, Korea, Republic of, 633-165
Local Institution Recruiting
Daegu, Korea, Republic of, 700-712
Local Institution Recruiting
Daejeon, Korea, Republic of, 301-721
Local Institution Recruiting
Gyeonggi-do, Korea, Republic of, 431-070
Local Institution Recruiting
Gyeonggi-do, Korea, Republic of, 443-721
Local Institution Recruiting
Gyeonggi-do, Korea, Republic of, 442-723
Local Institution Recruiting
Incheon, Korea, Republic of, 405-760
Local Institution Recruiting
Jeollabuk-do, Korea, Republic of, 561-712
Local Institution Recruiting
Jeonnam, Korea, Republic of, 519-763
Local Institution Recruiting
Seoul, Korea, Republic of, 158-710
Local Institution Recruiting
Seoul, Korea, Republic of, 110-746
Local Institution Recruiting
Seoul, Korea, Republic of, 137-701
Local Institution Recruiting
Seoul, Korea, Republic of, 138-736
Local Institution Recruiting
Seoul, Korea, Republic of, 152-703
Local Institution Recruiting
Ulsan, Korea, Republic of, 682-714
Local Institution Recruiting
Wonju, Korea, Republic of, 220-701
Philippines
Local Institution Recruiting
Batangas, Philippines
Local Institution Recruiting
Manilla, Philippines
Thailand
Local Institution Recruiting
Bangkok, Thailand
Sponsors and Collaborators
Il-Yang Pharm. Co., Ltd.
Investigators
Study Director: IL-YANG PHARM IL-YANG Pharmaceutical. Co., LTD
  More Information

No publications provided

Responsible Party: Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01511289     History of Changes
Other Study ID Numbers: IY5511A3001
Study First Received: January 3, 2012
Last Updated: September 24, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)
Indonesia: The National Agency of Drug and Food Control (NA-DFC)
Philippines: Bureau of Food and Drugs
Thailand: Ethical Committee

Keywords provided by Il-Yang Pharm. Co., Ltd.:
Radotinib
CML-CP
Chronic Myeloid Leukemia, chronic phase

Additional relevant MeSH terms:
Bone Marrow Diseases
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Hematologic Diseases
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014