A Phase III Study of Dasatinib vs. Imatinib in Patients With Newly Diagnosed Chronic Phase CML - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00481247

Purpose

The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 12 months after randomization in newly diagnosed chronic phase Ph+ CML patients. The safety of this treatment will also be studied

Condition	Intervention	Phase
Myeloid Leukemia, Chronic	Drug: Dasatinib Drug: Imatinib	Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate Dasatinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Best confirmed Complete Cytogenetic Response [ Time Frame: within 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time in, duration and time to confirmed CCyR [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Time in duration and time to confirmed CCyR [ Time Frame: within 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	518
Study Start Date:	September 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Dasatinib Tablets, oral, dasatinib 50-180 mg QD, once daily, 5-7 years
B: Active Comparator	Drug: Imatinib Tablets, oral, imatinib 200-800 mg, QD, once daily, 5-7 years

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male & Female ≥18 years
CP Ph+ CML
ECOG PS 0-2

Exclusion Criteria:

Pleural Effusion
Uncontrolled CV disease
Significant bleeding disorder unrelated to CML
Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481247

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 117 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-056
Study First Received:	May 30, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00481247
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bristol-Myers Squibb:

Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

Study placed in the following topic categories:

Philadelphia Chromosome
Chromosomal abnormalities
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase

Imatinib
Leukemia
Dasatinib
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chromosome Aberrations
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Translocation, Genetic

ClinicalTrials.gov processed this record on January 13, 2009