A Clinical Study 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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Relapsed Non Hodgkin Lymphoma
- Sponsor
- The First Affiliated Hospital of Soochow University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Overall Survival(OS)
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed B-NHL with extrinsic involvement.
- •Age ≥ 18 years and ≤ 65 years.
- •Measurable disease of at least 15mm(node)/10mm（extranodal）
- •Meet any of the following conditions :
- •After 4 courses of standard first-line treatment or 2 courses of treatment with more than two lines, the lesions decreased by less than 50%;2 B-NHL with disease progression after first-line or induction treatment;
- •Relapsed B-NHL within 12 months after ASCT;
- •After standard chemotherapy or hematopoietic stem cell transplantation, the size of any new lesions or the previously involved site which had achieved complete remission increased by 50% or more.
- •Receive standard autologous hematopoietic stem cell transplantation with CD34+ cells ≥2\*10\^6/kg.
- •Estimated survival time ≥3 months
Exclusion Criteria
- •Having received allogeneic hematopoietic stem cell transplantation previously;
- •HIV-positive;
- •Active hepatitis B or C infection;
- •Previous history of other malignant tumors. Excluded: Patients who had cured basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix at any time prior to the study; Patients with disease-free survival ≥5 years who had been cured by surgery only without further treatment for the other tumors listed above can be included in the study.
- •Patients with cardiac insufficiency:ejection fraction (EF) \< 30%, NYHA standard, grade II or above
- •Patients with liver and renal insufficiency: Serum Direct Bilirubin (SB) ≥2mg/ dL (34.2μmol/L), Aspartate Aminotransferase(AST) \> 2.5 times the up, Serum Creatinine (SCR) \> 2.5mg/ dL (221μmol/L)
- •Female patients who are pregnant, preparing to become pregnant or lactating.
- •The investigator believes that there are other factors that are not suitable for inclusion or affect subjects' participation or completion of the study.
Outcomes
Primary Outcomes
Overall Survival(OS)
Time Frame: up to 12 months
The interval from the time of ASCT to death from any cause or to the last follow-up moment.
Progression-free Survival(PFS)
Time Frame: up to 12 months
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.
Secondary Outcomes
- Overall Response Rate(ORR)(up to 12 months)
- Duration of Response(DOR)(up to 12 months)
- Adverse Events(AE)(Measured from start of treatment until 28 days after last treatment.)
- Cumulative Recurrence Rate(up to 12 months)