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This is a phase 2 study to investigate the efficacy and safety of DZD8586 in combination in participants with CLL/SLL.
This study consists of two parts: Part A is the safety lead-in phase, and Part B is the dose expansion phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of DZD8586 and Venetoclax | Experimental | DZD8586 will be taken orally once daily on days 1-28 of each cycle. Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DZD8586 | Drug | DZD8586 will be taken orally once daily on days 1-28 of each cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Incidence of Adverse Events | 30 days after the last dose | |
| Part B: 2-year progression free survival (PFS) rate assessed by investigator | Approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: PFS assessed by investigator | Approximately 5 years | |
| Part A: Objective response rate (ORR) assessed by investigator | Approximately 5 years | |
| Part B: ORR assessed by investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ling Zhou | Contact | 0086-21-61095755 | ling.zhou@dizalpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Niu | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Cancer Hospital | Recruiting | Hefei | Anhui | 230031 | China |
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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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| ID | Term |
|---|---|
| C579720 | venetoclax |
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| Venetoclax | Drug | Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1. |
|
| Approximately 5 years |
| Part B: Incidence of Adverse Events | 30 days after the last dose |
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
|
| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510280 | China |
|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450008 | China |
|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
|
| Yichang Central People's Hospital | Recruiting | Yichang | Hubei | 443003 | China |
|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
|
| The First People's Hospital of Changzhou | Recruiting | Changzhou | Jiangsu | 213003 | China |
|
| Affiliated Hospital of Nantong University | Recruiting | Nantong | Jiangsu | 226001 | China |
|
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
|
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
|
| Shengjing Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110004 | China |
|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310003 | 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 |