An Open-label, Randomized Study of Dasatinib vs High-dose (800-mg) Imatinib in the Treatment of Subjects With Chronic Phase Chronic Myeloid Leukemia Who Have Had a Suboptimal Response After at Least 3 Months of Therapy With 400 mg Imatinib
Participants were randomized 2:1 to dasatinib or high-dose imatinib, respectively.
Randomization was stratified by a suboptimal response, defined as a hematologic response
less than a complete hematologic response after at least 3 months of monotherapy with 400-mg
imatinib; a cytogenic response (CgR) less than a partial CgR (PCgR) after at least 6 months
of monotherapy with 400-mg; a PCgR after at least 12 months of monotherapy with 400-mg
imatinib; or less than a major molecular response with a complete CgR after at least 18
months of monotherapy with 400-mg imatinib.
Participants received either dasatinib or imatinib for 12 months or until disease
progression, unacceptable toxicity, consent withdrawal, or study discontinuation. After 12
months, who had a confirmed major molecular response and were still receiving dasatinib,
100 mg, or imatinib, 800 mg, were eligible to extend treatment for an additional 12 months.
Participants permanently discontinuing treatment before 12 months were considered treatment
failures and withdrawn from the study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants With Chronic Phase Chronic Myeloid Leukemia Who Have a Major Molecular Response (MMolR)
MMolR is defined as reduction in transcript levels of the breakpoint cluster region (BCR)-V-abl Abelson murine leukemia viral oncogene homolog 1 (ABL) gene of at least 3 log. The BCR-ABL gene has a role in the production of a mutated protein that converts bone marrow stem cells from normal to leukemic.
At 12 months from baseline
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)