Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
66 participants
INTERVENTIONAL
2025-09-22
2030-01-31
Brief Summary
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This study consists of two parts: Part A is the safety lead-in phase, and Part B is the dose expansion phase.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combination of DZD8586 and Venetoclax
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.
DZD8586
DZD8586 will be taken orally once daily on days 1-28 of each cycle.
Venetoclax
Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.
Interventions
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DZD8586
DZD8586 will be taken orally once daily on days 1-28 of each cycle.
Venetoclax
Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ECOG performance status 0-2, and life expectancy ≥ 6 months.
3. Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.
4. Patients with SLL must have at least one measurable lesion.
5. Adequate bone marrow reserve and organ functions.
6. Willing to comply with contraceptive restrictions.
Exclusion Criteria
2. Any unresolved \> grade 1 drug-related adverse events.
3. Known or suspected Richter's transformation, or prolymphocytic leukemia.
4. CNS involvement.
5. Active infection.
6. Any of severe cardiac or pulmonary abnormalities.
7. Poorly controlled autoimmune anemia or autoimmune thrombocytopenia.
8. Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
9. Prior malignancy within the past 3 years.
10. Known allergy to study drugs, any of the ingredients of the study drugs, or xanthine oxidase inhibitors or rasburicase.
18 Years
ALL
No
Sponsors
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Dizal (Jiangsu) Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Niu
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Ding
Role: primary
Jing
Role: primary
Li
Role: primary
Guo
Role: primary
Zhou
Role: primary
Fang
Role: primary
Cai
Role: primary
Zhou
Role: primary
Gu
Role: primary
Shi
Role: primary
Li
Role: primary
Bai
Role: primary
Yang
Role: primary
Niu
Role: primary
Yu
Role: primary
Other Identifiers
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DZ2025B0001
Identifier Type: -
Identifier Source: org_study_id