Hyper-CVAD and sequential blinatumomab for newly diagnosed Philadelphia chromosome-negative B-cell acute lymphocytic leukaemia: a single-arm, single-centre, phase 2 trial

Mené sur 38 patients atteints d'une leucémie lymphoïde aiguë Ph- récemment diagnostiquée (âge médian : 37 ans), cet essai de phase II évalue l'efficacité, du point de vue de la survie sans récidive, et la toxicité d'un traitement de première ligne combinant chimiothérapie intensive (de type hyper-CVAD) et blinatumomab dispensé de façon séquentielle

Résumé en anglais

Background : Blinatumomab is effective in relapsed or refractory B-cell acute lymphocytic leukaemiaand results in high rates of minimal residual disease negativity. We aimed to establishwhether the incorporation of blinatumomab into front-line therapy for acute lymphocyticleukaemia could improve outcomes.

Methods : We conducted a single-arm, phase 2 trial at The University of Texas MD Anderson CancerCenter (Houston, TX, USA). Patients aged 14 years or older with confirmed, newly diagnosedPhiladelphia chromosome (Ph)-negative B-cell acute lymphocytic leukaemia were eligible,including patients who had received up to one course of chemotherapy before enrolment.Patients received four cycles of intensive chemotherapy (hyper-CVAD [hyperfractionatedcyclophosphamide, vincristine, doxorubicin, and dexamethasone] alternating with high-dosemethotrexate and cytarabine), followed by four cycles of blinatumomab consolidation(up to 28