Interferon alpha was a therapy used in Chronic Myeloid Leukemia in Chronic phase prior to the advent of tyrosine kinase inhibitors. Synergistic effect of the combination of Peg-IFNα2a with Imatinib was demonstrated in the clinical SPIRIT trial. In this study, the investigators address the question of the efficacy and safety of dasatinib in combination with low dose of Peg-IFNα-2b as frontline therapy for patients with newly diagnosed Chronic Myeloid Leukemia in Chronic phase.
Study Type
INTERVENTIONAL
Dasatinib 100mg daily starting at inclusion If ANC ≤ 1.5.109/L, platelets ≤ 100.0.109/L or lymphocytes \> 4.0.109/L at 3 months, dasatinib will be continued alone, and patients will be still followed in the study
30 µg weekly starting month 4- month 21
Cumulative rate of molecular response
Molecular response 4.5 (MR4.5) is defined by either a positive BCR-ABL/ABL ratio ≤ 0.0032 on the international scale or by undetectable BCR-ABL with the analysis of at least 32000 copies of ABL (according to the ELN recommendations by N. Cross et al., leukemia 2012). Centralized analyses of molecular response by RTQPCR will be performed for all molecular assessments in this study.
Time frame: at 12 months.
Rate of complete cytogenetic response
Time frame: 3, 6, 12, 18, 24 months, and every 12 months thereafter.
Rate of major molecular responses
Time frame: 3, 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter.
Rate of molecular response
Rate of molecular response 4.5 and 5.0
Time frame: 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter.
Kinetics and duration
Cumulative rate, Kinetics and duration CCR, MMR, MR4.5, MR5.0
Time frame: 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter
Rate of PegIFN-α2b and dasatinib discontinuation
Time frame: 24 months
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