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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
One dose of CD19 CAR-T cells (1\*10e6 CAR+ T-cells/kg) by intravenous infusion.
Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Minsk, Minsk Oblast, Belarus
RECRUITINGIncidence of Treatment-Emergent Adverse Events
Adverse events will be graded according to the CTCAE v5.0
Time frame: 1 month
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).
Time frame: 28 days after CAR-T cells infusion
Overall survival (OS)
The proportion of patients with overall survival
Time frame: 1 year
Events free survival (EFS)
Time from CAR-T cells infusion to CR failure, relapse, or death.
Time frame: 1 year
Leukemia free survival (LFS)
Time from achievement of CR/CRi/CRm to the time of relapse, death in remission, or last follow-up.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.