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

Last updated: February 22, 2016
Sponsor: Il-Yang Pharm. Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Leukemia

Hematological Disorders

Red Blood Cell Disorders

Treatment

N/A

Clinical Study ID

NCT01511289
IY5511A3001
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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 forHydrea 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 tounderlying leukemia

  • Patients who had a major surgery within 4 weeks prior to study entry or has notrecovered from side effects of such surgery

Study Design

Total Participants: 242
Study Start date:
August 01, 2011
Estimated Completion Date:

Connect with a study center

  • Local Institution

    Mumbai,
    India

    Site Not Available

  • Local Institution

    New Delhi,
    India

    Site Not Available

  • Local Institution

    Jakarta,
    Indonesia

    Site Not Available

  • Local Institution

    Busan, 602-715
    Korea, Republic of

    Site Not Available

  • Local Institution

    Daegu, 700-712
    Korea, Republic of

    Site Not Available

  • Local Institution

    Daejeon, 301-721
    Korea, Republic of

    Site Not Available

  • Local Institution

    Gyeonggi-do, 431-070
    Korea, Republic of

    Site Not Available

  • Local Institution

    Incheon, 405-760
    Korea, Republic of

    Site Not Available

  • Local Institution

    Jeollabuk-do, 561-712
    Korea, Republic of

    Site Not Available

  • Local Institution

    Jeonnam, 519-763
    Korea, Republic of

    Site Not Available

  • Local Institution

    Seoul, 137-701
    Korea, Republic of

    Site Not Available

  • Local Institution

    Ulsan, 682-714
    Korea, Republic of

    Site Not Available

  • Local Institution

    Wonju, 220-701
    Korea, Republic of

    Site Not Available

  • Local Institution

    Batangas,
    Philippines

    Site Not Available

  • Local Institution

    Manilla,
    Philippines

    Site Not Available

  • Local Institution

    Bangkok,
    Thailand

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.