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This study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. 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 oral 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 event | 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianmo Sun | Contact | 0086-21-61097800 | Tianmo.Sun@dizalpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianyong Li | First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Hefei | Anhui | China | ||
| Research Site |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| DZD8586 | Drug | Daily oral dose of DZD8586 at 50 mg. |
|
|
| DZD8586 | Drug | Daily oral dose of DZD8586 at 75 mg. |
|
|
| Recruiting |
| Beijing |
| Beijing Municipality |
| 100053 |
| China |
| Research Site | Recruiting | Beijing | Beijing Municipality | 100191 | China |
| Research Site | Recruiting | Guangzhou | Guandong | 510280 | China |
| Research Site | Recruiting | Guangzhou | Guandong | 510515 | China |
| Research Site | Recruiting | Zhengzhou | Henan | China |
| Research Site | Recruiting | Wuhan | Hubei | China |
| First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | China |
| Research Site | Recruiting | Changchun | Jilin | China |
| Research Site | Not yet recruiting | Dalian | Liaoning | China |
| Research Site | Recruiting | Shenyang | Liaoning | China |
| Research Site | Recruiting | Jinan | Shandong | China |
| Research Site | Recruiting | Linyi | Shandong | China |
| Research Site | Recruiting | Shanghai | Shanghai Municipality | China |
| Research Site | Recruiting | Taiyuan | Shangxi | China |
| Research Site | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
| Research Site | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |