CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 150 enrolled
Drug / intervention
Dasatinib +1 moredrug
Likely dose
Dasatinib 20 mg or 50 mg twice daily (40-100 mg/day total)AI-extracted
Key inclusion· 6
  • ✓Age 18 years or older
  • ✓Chronic phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML)
  • ✓Documented imatinib resistance while receiving 400-600 mg/day dose
  • ✓No prior imatinib treatment exceeding 600 mg/day
Key exclusion· 10
  • ✕Prior imatinib treatment at doses exceeding 600 mg/day
  • ✕Previously identified BCR-ABL mutations
  • ✕Prior diagnosis of accelerated phase or blast crisis CML
  • ✕Intolerance to imatinib at any dose

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00103844
NCT00103844Phase 2Completed
CompareCT.gov

A Randomized Multi-Center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Imatinib at a Dose at 400 - 600 mg/d

Bristol-Myers Squibb·interventional·Posted Feb 16, 2005·Updated Aug 10, 2010

In Brief

A Phase 2 clinical trial evaluating Dasatinib and Imatinib for Chronic Myeloid Leukemia and Philadelphia-Positive Myeloid Leukemia. Completed, enrolled 150 participants across 131 sites in 32 countries.

Detailed Summary

The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Norway, Peru, Philippines, Poland, Puerto Rico, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 16, 2005
Enrollment StartFeb 1, 2005
Primary CompletionAug 1, 2006
Study CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 21.4 years ago

Interventions

Dasatinibdrug

Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks

Imatinibdrug

Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks