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This study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with Non-Hodgkin lymphoma
this study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with DLBCL or T cell lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| selinexor-based regimens | This study is a real-world study to explore the safety and efficacy of selinexor-based therapy in patients with lymphoma. It is planned to enroll 250 patients with lymphoma, including 150 patients with diffuse large B-cell lymphoma and 100 patients with peripheral T and NK/T-cell lymphoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selinexor | Drug | this is a real-world. Patients who use selinexor-based regimens in lymphoma will be followed up without interfering with the choice of treatment options for patients |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | the percentage of patients with complete response and partial response | throughout the study, an average of 1 year |
| incidence of adverse events/ serious adverse events | identify patterns of incidence in adverse events | throughout the study, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of dose delays or interruptions | calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall | throughout the study, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| duration of response (DOR) | DOR is calculated as the time from initial response (complete response or partial response) to date of progression or death, whichever is earlier | throughout the study, an average of 2 year |
Inclusion Criteria:
Exclusion Criteria:
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DLBCL, T or NK cell lymphoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao, Prof. | Contact | +862164370045 | 610707 | zwl_trial@163.com |
| Pengpeng Xu, Prof. | Contact | +862164370045 | 610707 | pengpeng_xu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C585161 | selinexor |
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|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | China |
|
| Union Hospital Affiliated to Huazhong University of Science and Technology | Recruiting | Wuhan | China |
|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |