Multicenter phase 2 trial of reduced-dose chemotherapy and blinatumomab induction for newly diagnosed Ph-negative B-cell precursor ALL

Blinatumomab has emerged as as promising component of first-line therapy for acute B-cell precursor lymphoblastic leukemia (BCP-ALL), bolstering treatment efficacy. A phase 2 trial at five centers in China evaluated reduced –dose chemotherapy (RDC), comprising idarubicin, vindesine, and dexamethasone over 7 days, followed by two weeks of blinatumomab as induction therapy for newly diagnosed Ph-negative BCP-ALL. The treatment resulted in complete remission in 33 of 35 patiënten (94%), with 30 (86%) achieving MRD-negativity. Two patients receive blinatumomab for another two weeks, resulting in complete remission in 35 of 35 patients and MRD negativity in 31 of 35 (89%). The median time to complete remission was 22 days. During induction therapy, no deaths occurred within 4 weeks, significantly lower than the 2-10% mortality rate observed with standard chemotherapy. ICANS (all grade 1) was seen in 14% of patients, while grade 3 or higher pneumonia, sepsis, and cytokine release syndrome occurred in 17%, 6%, and 9%, respectively. The 1-year overall survival and 1-year progression-free survival rates were 97.1% and 82.2%, respectively. The authors conclude that RDC followed by blinatumomab is an effective and well-tolerated induction regimen for newly diagnosed Ph-negative BCP-ALL.