Combination of an Anti-PD1 Antibody With Tisagenlecleucel Reinfusion in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia After Loss of Persistence

"Patients included first receive a lympho-depleting chemotherapy by Fludarabine / Cyclophosphamide. tisagenlecleucel infusion should then be administered 2 to 14 days after completion of chemotherapy.~Nivolumab (Opdivo®) will be given intravenously at 3mg/kg every 2 weeks. It will include patients with MRD negative disease status.~1. Four decreasing starting times for beginning nivolumab (day 14, day 11, day 5 and day -1) will be available for testing~2. Patients will be enrolled sequentially by cohorts of 3 with escalation between cohorts based only on the limiting toxicities between infusion and D28~Nivolumab will be given until 12 months after tisagenlecleucel infusion in case of response."

"It will include relapsed patients. Patients included first receive a lympho-depleting chemotherapy by Fludarabine / Cyclophosphamide. tisagenlecleucel infusion should then be administered 2 to 14 days after completion of chemotherapy.~Nivolumab (Opdivo®) will be given intravenously at 3mg/kg every 2 weeks.~-nivolumab starting at day -1.~Nivolumab will be given until 12 months after tisagenlecleucel infusion in case of response."