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This study is a follow-up study to update the survival time data (overall survival, progression-free survival, and duration of response) of the subjects who received SyB L-0501 at least once in Phase III Study of SyB L-0501 in combination with rituximab to treat recurrent/relapsed diffuse large B-cell lymphoma study (2017002) by reviewing their follow-up information following the study completion of Study 2017002.
In this study, the follow-up information gathered until the end of the investigation period is reviewed after obtaining informed consent from the subjects or their legal representatives. Accordingly, no intervention, such as administration of the investigational product or examination, will be performed.
Investigative methods
1. Survival status 2. Aggravation (progression or recurrence) 3. Drugs or procedures used for treatment of DLBCL or prophylaxis against its progression or recurrence 4. Occurrence of other malignant tumors
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The length of time from the date of case registration in Study 2017002 to the date of death from any cause. | Up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | The length of time from the date of treatment initiation (Day 1) in the first cycle in Study 2017002 to the date of progression (including recurrence/relapse), death from any cause, or censoring. | Up to 8 months |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
1. Subjects whose death was confirmed during the outcome investigation period in Study 2017002
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The study population includes subjects who received SyB L-0501 at least once in Phase III Study of SyB L-0501 in combination with rituximab to treat recurrent/relapsed diffuse large B-cell lymphoma study (2017002) and who (or their legal representatives) give informed consent.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nagoya | Aichi-ken | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35244756 | Derived | Murayama K, Kiguchi T, Izutsu K, Kameoka Y, Hidaka M, Kato H, Rai S, Kuroda J, Ishizawa K, Ichikawa S, Ando K, Ogura M, Fukushima K, Terui Y. Bendamustine plus rituximab in Japanese patients with relapsed or refractory diffuse large B-cell lymphoma. Ann Hematol. 2022 May;101(5):979-989. doi: 10.1007/s00277-022-04801-2. Epub 2022 Mar 4. |
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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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The length of time from the date when complete response (CR) or partial response (PR) was achieved in Study 2017002 to the date of progression (including recurrence/relapse), death from any cause, or censoring. |
| Up to 8 months |
| Matsuyama |
| Ehime |
| Japan |
| Research Site | Ōta | Gunma | Japan |
| Research Site | Fukuyama | Hiroshima | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Sayama | Osaka | Japan |
| Research Site | Izumo | Shimane | Japan |
| Research Site | Chuo-ku | Tokyo | Japan |
| Research Site | Koto | Tokyo | Japan |
| Research Site | Shinagawa-ku | Tokyo | Japan |
| Research Site | Akita | Japan |
| Research Site | Fukuoka | Japan |
| Research Site | Ibaraki | Japan |
| Research Site | Kyoto | Japan |
| Research Site | Nagasaki | Japan |
| Research Site | Osaka | Japan |
| Research Site | Yamagata | Japan |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |