NCT00101595

Dasatinib (BMS-354825) in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

A Phase II Study of BMS-354825 in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical research study is to learn if BMS-354825 will have activity as defined by hematologic responses in subjects with lymphoid blast phase chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia with primary or acquired resistance to imatinib mesylate.

Conditions

• Chronic Myeloid Leukemia
• Leukemia, Lymphoblastic, Acute, Philadelphia-positive

Interventions

Type	Name	Description
DRUG	Dasatinib	Tablets, Oral, 70 mg, twice daily, Until disease progression or untolerable toxicity, switch to the roll-over study or study closure

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-01-13
• Last updated: 2011-04-14

Locations

60 sites across 20 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Peru, South Korea, Sweden, Switzerland, United Kingdom