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Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia

Phase 1N = 83

Population
Chronic-phase CML in which treatment with interferon alfa had failed
Design
Phase 1 dose-escalating trial of STI571 (formerly CGP 57148B, later imatinib); patients were successively assigned to 1 of 14 doses.
Arms
  • STI571 (dose escalation) (experimental, n = 83): STI571 orally, 25 to 1000 mg per day across 14 dose levels
People
Druker BJ, senior author Sawyers CL
Show the numbers
Results reported for Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia
EndpointAnalysisSTI571 (dose escalation)ControlEffect
MCyRPatients treated with 300 mg or more per day (54 of the 83)0 to 35 percent of cells in metaphase positive for the Philadelphia chromosomeprimaryDruker 200131%—17 of 54 patients had a major cytogenetic response; 7 of these 17 had complete cytogenetic remissions. Complete hematologic responses occurred in 53 of 54 patients at 300 mg or more daily (counts only; no percentage is published).
Results reported for Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia
EndpointAnalysisSTI571 (dose escalation)ControlEffect
MCyRPatients treated with 300 mg or more per day (54 of the 83)0 to 35 percent of cells in metaphase positive for the Philadelphia chromosomeprimaryDruker 200131%—17 of 54 patients had a major cytogenetic response; 7 of these 17 had complete cytogenetic remissions. Complete hematologic responses occurred in 53 of 54 patients at 300 mg or more daily (counts only; no percentage is published).
Primary publication: Druker BJ, Talpaz M, Resta DJ, et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med. 2001;344(14):1031-1037. PubMedDOI

Appears in

Sources

  1. Druker BJ, Talpaz M, Resta DJ, et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med. 2001;344(14):1031-1037.

    PubMedDOI