Chimeric antigen receptor T-cell (CAR-T) therapy has achieved remarkable efficacy in B-cell acute lymphoblastic leukemia (B-ALL). However, relapse after CAR-T has been a major issue. Multi-antigen CAR T and combination with other regimens may reduce the relapse rate. We conducted CD22/CD19 CAR T-cells and blinatumoab combined with auto-HSCT "sandwich " strategy as consolidation therapy in patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The patients received blinatumoab after standard induction and consolidation chemotherapy. Autologous stem cells mobilization and collection were performed after blinatumomab. Auto-HSCT was proceeded after successful stem cell collection. CD22 and CD19 CAR-T cells were re-infused 2 days after stem cell reinfusion.
Overall survival
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive
Time frame: 2 years
leukemia free survival
It is measured from the date of achievement of a remission after blinatumomab until the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.
Time frame: 2 years
Number of adverse events
Adverse events are evaluated with CTCAE V5.0 among Sandwich stratergy.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.