The planned trial offers treatment cohorts for patients with full cytologic relapse (R/R ALL - Cohort 1), as well as for patients with molecular failure/relapse (MRD+ ALL - Cohort 2). Basically, the study aims to develop data for optimization of first-line therapy of T-ALL, either by modification of standard induction with Isatuximab or by establishing a post-induction therapy for eradication of MRD and thereby evaluates in parallel two different strategies.
early relapse within 12 months from first achievement of CR or
late relapse later than 12 months from first achievement of CR or
primary refractory disease without any CR or
any relapse after stem cell transplantation or
Extramedullary involvement except for non-bulky (<7.5 cm) lymph node involvement, splenomegaly, or hepatomegaly
Patients who have received prior antileukemic immunotherapy within 2 weeks prior to start of Isatuximab treatment
Patients who have received treatment for leukemia with chemotherapy within 2 weeks prior to start of Isatuximab treatment (exception: pre-phase therapy with 5-7 days of Dexamethasone, 3 days of Cyclophosphamide; intrathecal prophylaxis)
Patients who are candidates for a treatment with Nelarabine
Goethe University
Lead sponsor
Sanofi
Collaborator