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It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.
Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T treatment | Experimental | In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T | Combination Product | CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells. |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission rate | complete remission rate after treated by CAR-T therapy | every 3 months until 20 months after the last patient's enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | from date of inclusion to date of progression, relapse, or death from any cause | from the day of treatment to the date of first documented progression,up to 20 months after the last patient's enrollment |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
All the data would be available on the corresponding website of the leading research center.
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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from the date of inclusion to date of death, irrespective of cause
| 20 months after the last patient's enrollment |
| adverse events | any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure | from the date of the start of treatment to 20 months after last patient's enrollment |
| duration of the modified T cells by CAR-T in the patients | time from re-transfusion to date when the modified T cells become non-detectable. | from the date of re-transfusison to 20 months after last patient's enrollment |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |