Multicenter, Open-label, Non-randomized Phase II Trial of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CP-CML) Who Meet Criteria for Late Suboptimal Response After Prior Imatinib Treatment
This is a single-arm, open-label, phase II trial for patients in complete cytogenetic
response that have not achieved major molecular response or have lost a prior major
molecular response, after at least 18 months of treatment with imatinib.
All enrolled patients will receive dasatinib 100 mg once daily orally for 1 year until
progression, loss of cytogenetic response, transformation to advanced phases, unacceptable
toxicity (clinical adverse event, lab abnormality or concurrent disease), pregnancy if a
female or withdrawal of consent, whichever happens first. Patients will undergo BCR-ABL
assessments at study entry and every 3 months (central lab) and immunophenotyping and
studies for clonal lymphocytosis at study entry, at 3 and 6 months.
Cytogenetic assessment will be done only if loss of response/progression/clonal evolution
Subjects will be evaluated for the efficacy and safety of dasatinib (Sprycel). Lymphocytosis
data will be collected for all patients and separate description for efficacy and safety
parameters will be done in patients with and without lymphocytosis.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Asses the efficacy
To assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600
Steegmann Juan Luis, Dr
Spain: Health Ministry