A Study of ASCT Bridging CART Cell Therapy in Relapsed/Refractory B-cell Lymphoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ASCT Without CART Patients who undergone ASCT successfully and did not receive CART cell infusion. |
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| ASCT Bridging CART Patients who undergone ASCT and received CART cell infusion sequently within 1 month. Patients with disease recurrence or progression prior to the infusion of CART cells will be excluded. |
Outcome Measures
Primary Outcome Measures
- Progression-free Survival(PFS) [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.
- Overall Survival(OS) [up to 12 months]
The interval from the time of ASCT to death from any cause or to the last follow-up moment.
Secondary Outcome Measures
- Duration of Response(DOR) [up to 12 months]
DOR will be assessed from ASCT to progression,death or last follow-up.
- Adverse Events(AE) [Measured from start of treatment until 28 days after last treatment.]
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
- Overall Response Rate(ORR) [up to 12 months]
Number of patients who achieved response after the treatment.
- Cumulative Recurrence Rate [up to 12 months]
Cumulative number of patients who recurred after the treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed B-NHL with extrinsic involvement.
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Age ≥ 18 years and ≤ 65 years.
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Measurable disease of at least 15mm(node)/10mm（extranodal）
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Meet any of the following conditions :1. 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;3. Relapsed B-NHL within 12 months after ASCT;4. 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.
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Receive standard autologous hematopoietic stem cell transplantation with CD34+ cells ≥2*10^6/kg.
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Estimated survival time ≥3 months
Exclusion Criteria:
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Having received allogeneic hematopoietic stem cell transplantation previously;
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HIV-positive;
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Active hepatitis B or C infection;
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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.
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Patients with cardiac insufficiency:ejection fraction (EF) < 30%, NYHA standard, grade II or above
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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)
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Female patients who are pregnant, preparing to become pregnant or lactating.
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The investigator believes that there are other factors that are not suitable for inclusion or affect subjects' participation or completion of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China | 215000 |
Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Investigators
- Study Chair: Depei Wu, The First Affiliated Hospital of Soochow University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020173