Refractory and relapsed (R/R) acute lymphoblastic leukemia (ALL) patients with active disease always have a dismal outcome. Chimeric antigen receptor (CAR) T-cell therapy targeting to Cluster of Differentiation Antigen 19 (CD19) has been proved as a potent approach to attain remission in B-cell R/R patients. Therefore, the investigators conduct atrial to evaluate the the efficacy and safety of locally producing CAR T cells targeting CD19, and to analyze the outcome of enrolled B-cell ALL patients with active disease or persistent residual disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Patients enrolled will receive infusion of CD19-targeting CAR T-cells with a target dose of 5\~10×10E6/kg of recipient weight, after the preparative regimen consisted of fludarabin (30mg/m2, day -5 to -3) and cyclophosphamide (300mg/m2, day -5 to -3).
The Fisrt Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Completeremission
defined as less than 5% blasts in the bone marrow without myelosuppression, no circulating blasts in peripheral blood, and the absence of extramedullary disease, regardless of cell count recovery
Time frame: 1 month post infusion
Minimal residual disease response
defined as less than 0.01% bone marrow blasts assessed by multiparameter flow cytometry, and absence of genetic aberrants assessed by karyotype analysis or molecular detection
Time frame: 1 month post infusion
Leukemia-free survival
calculating from the day of CAR T-cell infusion to death, disease progression or the end of follow-up
Time frame: 3 year post infusion
Overall survival
calculating from the day of CAR T-cell infusion to death or the end of follow-up
Time frame: 3 year post infusion
Cumulative incidence of relapse
calculating from the day of CAR T-cell infusion to disease progression or the end of follow-up
Time frame: 3 year post infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.