Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
Current studies have shown that under standard treatment, patients with large masses and high-grade DLBCL have a poor prognosis. Data from major centers around the world on CAR-T cell treatment of relapsed and refractory B-cell NHL show that CAR-T treatment of relapsed and refractory B-cell NHL has a low complete remission rate but a low recurrence rate after remission.Therefore, new treatment options are urgently needed to achieve long-term relief. CD19 CAR-T therapy as a consolidation therapy after high-dose melphalan and autologous hematopoietic stem cell transplantation has been used in a refractory MM patient at the University of Pennsylvania, and good research progress has been made. Craig S et al. studied the safety and effectiveness of CD19 CAR-T cell therapy after high-dose chemotherapy and autologous stem cell transplantation HDT-ASCT. The object of the study was relapsed and refractory non-Hodgkin's lymphoma, with 2-year progression-free survival ( PFS) is 30%. Therefore, autologous hematopoietic stem cell transplantation combined with CAR-T cell therapy is expected to improve the complete remission rate and long-term survival rate. In summary, the center intends to apply for a clinical trial of autologous hematopoietic stem cell transplantation combined with CAR-T cells for the treatment of refractory and relapsed non-Hodgkin's lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The patient receives ECHOP chemotherapy or other chemotherapy regimens; G-CSF in the low cell stage mobilizes hematopoietic stem cells and freezes them for later use after collection; Autologous hematopoietic stem cells and prepared CD19 CAR-T cells are reinfused into the patient
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGoverall response rate
the number of response patients/the number of total patients
Time frame: Up to 30 months
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame: 24 months after cell infusion
Overall response rate(ORR)
Assessment of ORR (ORR = CR + CRi ) at Month 1,3,6,12,18and 24
Time frame: Month 1,3,6,12,18and 24
Progression-free survival (PFS)
Assessment of PFS at Month 6,12,18and 24
Time frame: Month 6,12,18and 24
Overall survival (OS)
Assessment of OS at Month 6,12,18and 24
Time frame: Month 6,12,18and 24
Duration of response(DOR)
Assessment of OS at Month 6,12,18and 24
Time frame: Month 6,12,18and 24
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