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A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

NCT00481247 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 547

Last updated 2017-02-15

Study results available
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Summary

The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.

Conditions

  • Myeloid Leukemia, Chronic

Interventions

DRUG

Dasatinib

Tablets, oral, dasatinib 50-140 mg once daily (QD)

DRUG

Imatinib

Tablets, oral, imatinib 200-800 mg, QD

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-12-31
Completion
2015-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Chile
  • China
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00481247 on ClinicalTrials.gov