The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
CD19+ relapsed or refractory lymphoblastic leukemia/lymphoma;
Karnofsky or Lansky performance scale greater or equal to 70;
T-cells count in peripheral blood >150 cells/µL;
Written informed consent.
primary immunodeficiencies or genetic syndromes;
neurologic diseases;
autoimmune diseases or polyallergie;
transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion;
Single group
CD19 CAR-T-cells
Biological/VaccineOne dose of CD19 CAR-T cells (1\*10e6 CAR+ T-cells/kg) by intravenous infusion.
Tocilizumab
DrugBefore 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).
Incidence of Treatment-Emergent Adverse Events
Adverse events will be graded according to the CTCAE v5.0
Objective Response Rate (ORR) (CR+CRi+CRm)
The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), complete molecular remission (CRm).
Overall survival (OS)
The proportion of patients with overall survival
Events free survival (EFS)
Time from CAR-T cells infusion to CR failure, relapse, or death.
Leukemia free survival (LFS)
Time from achievement of CR/CRi/CRm to the time of relapse, death in remission, or last follow-up.
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BelarusClick on the lead sponsor to view all of their trials.