This is a single center, prospective cohort study to to evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation(ASCT) bridging chimeric antigen receptor T (CART) cell therapy in the treatment of relapsed/refractory B-cell non-Hodgkin's lymphoma.
High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation(ASCT) is still the standard salvage treatment for relapsed/refractory B-cell non-Hodgkin's lymphoma (R/R B-NHL). However, its overall survival (OS) and event-free survival (EFS) of 3 years and above are less than 50%. Chimeric antigen receptor T (CART) cell therapy has shown great efficacy in treating B-NHL in recent years. Preclinical studies have indicated that the infusion of hematopoietic stem cells could promote the amplification and function of adoptive metastatic anti-tumor CD8+T cells, providing a certain theoretical basis for ASCT combined with CART cell therapy. In order to evaluate the efficacy and safety of ASCT bridging CART cell therapy in treating R/R B-NHL, we conduct this single center, prospective cohort study.
Study Type
OBSERVATIONAL
Enrollment
100
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Progression-free Survival(PFS)
The last follow-up of a surviving patient after ASCT to the date of relapse, disease progression, death, dependent upon which occurred first over a follow-up period of 18 months.
Time frame: up to 12 months
Overall Survival(OS)
The interval from the time of ASCT to death from any cause or to the last follow-up moment.
Time frame: up to 12 months
Duration of Response(DOR)
DOR will be assessed from ASCT to progression,death or last follow-up.
Time frame: up to 12 months
Adverse Events(AE)
Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated
Time frame: Measured from start of treatment until 28 days after last treatment.
Overall Response Rate(ORR)
Number of patients who achieved response after the treatment.
Time frame: up to 12 months
Cumulative Recurrence Rate
Cumulative number of patients who recurred after the treatment.
Time frame: up to 12 months
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