Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia.
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia and determine the best dosage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
177
T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor
Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days
Hebei Yanda Ludaopei Hospital
Beijing, China
Occurrence of study related adverse events
defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
Time frame: 2 years
Overall response rate
An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry
Time frame: 2 years
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