At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 638 enrolled
Drug / intervention
dasatinib +1 moredrug
Likely dose
Dasatinib 70 mg orally twice daily or 140 mg orally once dailyAI-extracted
Key inclusion· 5
- ✓Ph+/BCR-ABL+ accelerated phase CML, blast phase CML, or Ph+ ALL with primary or acquired hematologic resistance to imatinib or imatinib intolerance
- ✓Age ≥18 years
- ✓ECOG performance status 0-2
- ✓Adequate hepatic function
Key exclusion· 9
- ✕Pregnant or breastfeeding women
- ✕Serious uncontrolled medical disorder or active infection
- ✕Uncontrolled or significant cardiovascular disease
- ✕Concurrent medications that increase bleeding risk
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)
In Brief
A Phase 3 clinical trial evaluating dasatinib for Myeloid Leukemia, Chronic, Accelerated Phase and Leukemia, Lymphoblastic, Acute, Philadelphia-Positive. Completed, enrolled 638 participants across 119 sites in 32 countries.
Detailed Summary
This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloid Leukemia, Chronic, Accelerated Phase, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
First PostedJul 2005
Primary CompletionNov 2006
Study CompletionJun 2013
TodayJul 2026
First PostedJul 25, 2005
Enrollment StartJun 1, 2005
Primary CompletionNov 1, 2006
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 20.9 years ago
Interventions
dasatinibdrug
Tablets, Oral, 70 mg BID, indefinitely, survival study
dasatinibdrug
Tablets, Oral, 140 mg QD, indefinitely, survival study