It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients. Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.
The first affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China
complete remission rate
complete remission rate after treated by CAR-T therapy
Time frame: every 3 months until 20 months after the last patient's enrollment
progression free survival
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: from the day of treatment to the date of first documented progression,up to 20 months after the last patient's enrollment
overall survival
from the date of inclusion to date of death, irrespective of cause
Time frame: 20 months after the last patient's enrollment
adverse events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Time frame: from the date of the start of treatment to 20 months after last patient's enrollment
duration of the modified T cells by CAR-T in the patients
time from re-transfusion to date when the modified T cells become non-detectable.
Time frame: from the date of re-transfusison to 20 months after last patient's enrollment
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