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Bending the Curve Trial by Trial
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DASISION

Needs review

Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia

Phase 3N = 519NCT00481247

Population
Newly diagnosed chronic-phase CML
Design
Multinational, open-label randomized phase 3 study of dasatinib versus imatinib as first-line treatment of chronic-phase CML; minimum follow-up of 12 months for the primary analysis; final 5-year analysis reported separately.
Primary endpoint
CCyR
Arms
  • Dasatinib (experimental, n = 259): Dasatinib 100 mg once daily
  • Imatinib (control, n = 260): Imatinib 400 mg once daily
People
Kantarjian H, senior author Baccarani M
Δ CCyR+11 pointsΔ CCyR+11 pointsΔ MMR+18 points
Show the numbers
Results reported for DASISION
EndpointAnalysisDasatinibImatinibEffect
CCyRRandomly assigned patients (analysis population not stated in the abstract)Complete cytogenetic response by 12 months, confirmed on two consecutive assessments at least 28 days apart (primary endpoint)primaryKantarjian 201077%66%P=0.007
CCyRRandomly assigned patients (analysis population not stated in the abstract)Complete cytogenetic response observed on at least one assessment by 12 monthsprimaryKantarjian 201083%72%P=0.001
MMRRandomly assigned patients (analysis population not stated in the abstract)Major molecular response by 12 months (secondary endpoint, tested at a significance level of 0.0001)primaryKantarjian 201046%28%P<0.0001
Results reported for DASISION
EndpointAnalysisDasatinibImatinibEffect
CCyRRandomly assigned patients (analysis population not stated in the abstract)Complete cytogenetic response by 12 months, confirmed on two consecutive assessments at least 28 days apart (primary endpoint)primaryKantarjian 201077%66%P=0.007
CCyRRandomly assigned patients (analysis population not stated in the abstract)Complete cytogenetic response observed on at least one assessment by 12 monthsprimaryKantarjian 201083%72%P=0.001
MMRRandomly assigned patients (analysis population not stated in the abstract)Major molecular response by 12 months (secondary endpoint, tested at a significance level of 0.0001)primaryKantarjian 201046%28%P<0.0001
Primary publication: Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010;362(24):2260-70. PubMedDOI

Appears in

Sources

  1. Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010;362(24):2260-70.

    PubMedDOI