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This study aims to collect clinical data from adult patients with relapsed or refractory non-Hodgkin's lymphoma (r/r NHL) receiving cellular immunotherapy to establish a large database of cellular immunotherapy for Chinese patients.
This study aims to collect efficacy and safety data from adult patients with r/r NHL who received cellular immunotherapy between January 2017 and December 2040. Study investigators will determine the most appropriate diagnostic and treatment plans for patients based on clinical practice, without any intervention due to the existence of this study. No grouping will be conducted, and subgroup analyses will be performed based on the collected data.
Data collection process:
Clinical data will be collected from patients before cellular immunotherapy, before immune cell infusion, on the day of infusion, and at the last visit or follow-up within 24 months post-infusion. This includes collecting efficacy data, adverse events related to cellular immunotherapy, and survival data. Additionally, any new tumors, pathological findings, and other relevant laboratory or auxiliary examination data will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T | Chimeric antigen receptor modified T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chimeric Antigen Receptor | Drug | CAR-T |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) Rate in 3 months | Complete Response rate in 3 months is defined as the incidence of subjects achieving complete remission (CR) within 3 months after CAR-T infusion according to the Lugano Classification (Cheson et al, 2014), as determined by study investigators. | 3 months post CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective remission rate (ORR) in 3months | ORR in 3 moths is defined as the incidence of either a CR or a partial response (PR) within 3 months after CAR-T infusion per the Lugano Classification as determined by study investigators. | 3 months post CAR-T infusion |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with relapsed or refractory lymphoma receiving cellular immunotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao | Contact | +862164370045 | zwl_trial@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Shanghai Institute of Hematology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 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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| ID | Term |
|---|---|
| D000076962 | Receptors, Chimeric Antigen |
| ID | Term |
|---|---|
| D062165 | Receptors, Artificial |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
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OS is defined as the time from CAR-T infusion to the date of death from any cause. |
| 2 years post CAR-T infusion |
| Adverse events (AEs) | Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter | 2 years post CAR-T infusion |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011948 | Receptors, Antigen, T-Cell |
| D011946 | Receptors, Antigen |
| D011971 | Receptors, Immunologic |
| D018160 | Receptors, Cytoplasmic and Nuclear |