This study aims at exploring the activity of a frontline approach based on dasatinib plus steroids administration as induction treatment, followed by the infusion of Blinatumomab, in adult Ph+ ALL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Adult Ph+ ALL (≥18 years old, with no upper age limit) patients will begin treatment with Dasatinib, 140 mg/day, from day 1 to day +84.
Upon induction: patients in CHR will receive Blinatumomab at a dose of 15 µg/m²/day as continuous intravenous infusion (CIVI) at a constant flow rate for four weeks, followed by a two-week infusion-free interval, defined as one treatment cycle. At least 2 cycles should be administered, up to a maximum of 5 cycles, if deemed necessary.
Number of patients who achieve Minimal Residual Disease (MRD) negativity upon treatment
In particular, after 2 cycles of blinatumomab. Minimal Residual Disease (MRD) negativity is intended as Complete Molecular Remission (CMR)
Time frame: After 11 months from study entry
Number of patients completing the 2 cycles of blinatumomab and alive in first complete hematologic remission (CHR)
Time frame: From day +85 at 12 months
Number of patients at Complete Molecular Response (CMR)
Time frame: At day +22, +45, +57 and +85 from study entry
Number of months of the CMR
Time frame: At 12 and 24 months
Number of patients in Overall Survival (OS)
Time frame: At 12 and 24 months
Number of grade >3 adverse events
Time frame: At 12 and 24 months
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