Study of Dasatinib in Patients With Chronic Phase CML and a Suboptimal Response to Imatinib - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00320190

Purpose

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.

Condition	Intervention	Phase
Leukemia, Myeloid, Chronic	Drug: Dasatinib Drug: Imatinib	Phase II 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, Efficacy Study
Official Title:	An Open-Label, Randomized Study of Dasatinib vs. High-Dose (800 mg) Imatinib in the Treatment of Subjects With Chronic Phase Chronic Myeloid Leukemia Who Have Had a Suboptimal Response After at Least 3 Months of Therapy With 400 mg Imatinib

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Rate of major molecular response [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rates of complete cytogenetic responses measure [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
Time to major molecular response [ Time Frame: measured every 3 months ] [ Designated as safety issue: No ]
Safety of dasatinib and high-dose imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	32
Study Start Date:	August 2006
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Dasatinib Tablets, Oral, 100 mg, once daily, 24 months
2: Active Comparator	Drug: Imatinib Tablets, Oral, 400 mg, twice daily, 24 months

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320190

Show 25 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:	CA180-043, EUDRACT Number: 2005-005153-22
Study First Received:	May 1, 2006
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00320190
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Bristol-Myers Squibb:

Chronic phase CML, with a suboptimal response after treatment with imatinib

Study placed in the following topic categories:

Imatinib
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Dasatinib

Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

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

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009