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| Name | Class |
|---|---|
| Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASCT Without CART | Patients who undergone ASCT successfully and did not receive CART cell infusion. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response(DOR) | DOR will be assessed from ASCT to progression,death or last follow-up. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The total number of patients was 60.
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| Name | Affiliation | Role |
|---|---|---|
| Depei Wu | The First Affiliated Hospital of Soochow University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Measured from start of treatment until 28 days after last treatment. |
| Overall Response Rate(ORR) | Number of patients who achieved response after the treatment. | up to 12 months |
| Cumulative Recurrence Rate | Cumulative number of patients who recurred after the treatment. | up to 12 months |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |