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This study will treat patients with DLBCL whose disease comes back or is not responding to prior therapy. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily dose of DZD8586 at 25 mg | Experimental |
| |
| Daily dose of DZD8586 at 50 mg | Experimental |
| |
| Daily dose of DZD8586 at 75 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DZD8586 | Drug | Daily dose of DZD8586 at 25 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate assessed by investigators | Assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 30 days after the last dose, assessed up to 2 years |
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Inclusion Criteria:
Participants who meet all the following criteria:
Exclusion Criteria:
Participants who meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lugui Qiu | National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hefei | Anhui | 230031 | China | ||
| Research Site |
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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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| DZD8586 |
| Drug |
Daily dose of DZD8586 at 50 mg |
|
| DZD8586 | Drug | Daily dose of DZD8586 at 75 mg |
|
| Beijing |
| Beijing Municipality |
| 100083 |
| China |
| Research Site | Guangzhou | Guangdong | 510060 | China |
| Research Site | Nanning | Guangxi | 530016 | China |
| Research Site | Zhengzhou | Henan | 450003 | China |
| Research Site | Wuhan | Hubei | 430023 | China |
| Research Site | Changsha | Hunan | 410031 | China |
| Research Site | Jinan | Shandong | 250117 | China |
| Research Site | Linyi | Shandong | 276002 | China |
| Research Site | Xi’an | Shanxi | 710061 | China |
| Research Site | Chengdu | Sichuan | 610041 | China |
| National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College | Tianjin | Tianjin Municipality | 300020 | China |
| Research Site | Tianjin | Tianjin Municipality | 300181 | China |
| Research Site | Hangzhou | Zhejiang | 310009 | China |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |