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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imatinib

Imatinib 400mg QD

Group Type ACTIVE_COMPARATOR

Imatinib

Intervention Type DRUG

400mg/Tab, QD

Radotinib 600mg

Radotinib 300mg BID

Group Type EXPERIMENTAL

Radotinib

Intervention Type DRUG

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

Radotinib 800mg

Radotinib 400mg BID

Group Type EXPERIMENTAL

Radotinib

Intervention Type DRUG

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

Interventions

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Imatinib

400mg/Tab, QD

Intervention Type DRUG

Radotinib

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

Intervention Type DRUG

Other Intervention Names

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Glivec Gleevec IY5511HCl

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No