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To assess the clinical outcomes following treatment with Pola in combination with Bendamustine, Rituximab (BR) or Rituximab (R) in patients with R/R DLBCL who are not eligible for transplantation in the real-world setting.
This study is a multi-center retrospective observational study. It aims to evaluate the effectiveness and safety of polatuzumab vedotin treatment in patients with hematopoietic stem cell transplantation ineligible relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), who met the criteria to access Pola through the compassionate use program (CUP). Based on the medical records of patients in the four participating hospitals, the study database will be established by using the unified case report form (CRF) to search extract information the data of target population from the hospital database, that is, the variables without personal identification information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pola BR/R | Patients with R/R DLBCL who are enrolled in the Pola CUP program in China, and treated with Pola-BR or Pola-R regimens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polatuzumab Vedotin-Piiq | Drug | Patients will receive a total of six cycles of Pola in combination with rituximab and bendamustine or in combination with only rituximab. A cycle is typically 21 days for DLBCL. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed best overall response (BOR) | Best overall response (BOR) assessed by the investigator, is based on either PET-CT or CT, and defined as the percentage of patients with CR or PR. | From the start of the treatment until the date of first documented progression or the completion of the treatment(up to six cycles, each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response rate (ORR) assessed by the investigator at the end of treatment (EOT), is defined as the percentage of patients with CR or PR at the end of treatment. | At end of the treatment(up to six cycles, each cycle is 21 days) |
| Duration of response (DOR) |
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Inclusion Criteria:
Hospitalized patients Patients who enrolled in the Pola CUP program and met the following criteria:
Exclusion Criteria:
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All patients enrolled in the Pola CUP program in China
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianqiu Wu, Ph.D | Contact | +86-13951671579 | wujq211@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jifeng Feng, Ph.D | Jiangsu Cancer Institute & Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000600736 | polatuzumab vedotin |
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|
DOR is defined as the time from initial complete response (CR) or partial response (PR) to disease progression, relapse, or death from any cause, whichever occurred first. |
| From initial CR or PR to disease progression, relapse, or death from any cause, whichever occurred first, assessed up to 25 months |
| Complete response (CR) | CR rate is defined as the percentage of patients with CR. | At end of the treatment(up to six cycles, each cycle is 21 days) |
| Progression free survival (PFS) | PFS is defined as the time from the start of treatment until disease progression, relapse, or death from any cause, whichever occurred first. | From the start of treatment until disease progression, relapse, or death from any cause, whichever occurred first,assessed up to 30 months |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |