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OpenTrials
Completed

NCT Number: NCT01511289

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

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).

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Key information

Conditions

Leukemia Bone Marrow Diseases Chromosome Aberrations Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Philadelphia Chromosome Translocation, Genetic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Jakarta, Indonesia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imatinib

Drug

400mg/Tab, QD

Other names: Glivec, Gleevec

Radotinib

Drug

100mg or 200mg/Capsule, 300mg or 400mg BID

Other names: IY5511HCl

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. Rate of subjects with disease progression

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Il-Yang Pharm. Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
First posted
Jan 18, 2012
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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