Overview
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.
Description
Locally manufactured second generation autologous CD19 CAR-T cells are used for immunotherapy. Protocol treatment includes lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one CAR-T cells intravenous infusion with tocilizumab premedication.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- primary immunodeficiencies or genetic syndromes;
- neurologic diseases;
- autoimmune diseases or polyallergie;
- transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion;
- GvHD grade 2-4;
- uncontrolled systemic infection;
- hypoxia (Sp02<90%)
- severe hepatic dysfunction: ALT or AST >=3x upper limit of normal for age;
- renal dysfunction: serum creatinine level >=3x upper limit of normal for age;
- positive serology for human immunodeficiency virus (HIV), active hepatite C or B;
- pregnancy.