Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	18 and over	Pharmaceutical / Industry	CA180-043 EUDRACT Number: 2005-005153-22, NCT00320190

Trial Description

Summary

The purpose of this study is to compare the efficacy of dasatinib to high-dose imatinib (800 mg) in patients with chronic phase chronic myeloid leukemia (CML) who achieved a suboptimal response after at least 3 months of imatinib (400 mg) monotherapy.

The safety of these treatments will also be studied.

Eligibility Criteria

Inclusion Criteria:

• Subjects with chronic phase CML who achieved only a suboptimal response (defined as a hematologic response which is less than CHR after at least 3 months with imatinib 400 mg monotherapy; or a cytogenetic response which is less than a PCgR after at least 6 months with imatinib 400 mg or a PCgR after at least 12 months therapy with imatinib 400 mg monotherapy or less than MMolR with CCgR after at least 18 months therapy with imatinib 400 mg monotherapy). Only subjects who started treatment with imatinib 400 mg monotherapy within 6 months of initial CML diagnosis will be eligible.

• Men and women, 18 years of age and older

Exclusion Criteria:

• Previous diagnosis of accelerated phase or blast crisis CML

• Uncontrolled or significant cardiovascular disease

• History of significant bleeding disorder unrelated to CML

• Concurrent other malignancies other than CML

• Intolerance to imatinib 400 mg.

• Prior treatment with imatinib at a dose > 400 mg

• Subjects with prior stem cell transplantation and/or high dose chemotherapy for CML

Trial Contact Information

Trial Lead Organizations/Sponsors

Bristol-Myers Squibb Company - New York

Bristol-Myers Squibb

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00320190
Information obtained from ClinicalTrials.gov on May 07, 2009