Actively Recruiting
A Phase 2 Study of DZD8586 Combination Therapy in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)
Led by Dizal (Jiangsu) Pharmaceutical Co., Ltd. · Updated on 2025-12-24
66
Participants Needed
15
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination of DZD8586 and Venetoclax in adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). This phase 2 study includes two parts: an initial safety lead-in phase (Part A) and a dose expansion phase (Part B), aiming to better understand the treatment's impact on these conditions. Participants will take DZD8586 orally once daily for 28 days in each cycle. Venetoclax is also taken orally once daily for 28 days, but starting from the first day of the fourth cycle. The study carefully monitors participants during these treatment periods to assess safety and response. During the study, participants undergo regular assessments including monitoring for adverse events during and after treatment. The main outcomes include the incidence of side effects within 30 days after the last dose and the progression-free survival rate over approximately 5 years. Researchers will also evaluate response rates and continue safety monitoring to gather comprehensive data on the treatment combination's effects.
CONDITIONS
Brief Title
A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female 18 years of age or older
- ECOG performance status of 0 to 2 with life expectancy of at least 6 months
- Newly diagnosed or treatment-naive chronic lymphocytic leukemia or small lymphocytic lymphoma needing treatment
- For SLL patients, at least one measurable lesion
- Adequate bone marrow function and organ health
- Willingness to follow contraceptive restrictions
You will not qualify if you...
- Previous or current treatments not allowed by the study protocol
- Any unresolved drug-related side effects above grade 1
- Known or suspected Richter's transformation or prolymphocytic leukemia
- Central nervous system involvement
- Active infection
- Severe heart or lung problems
- Poorly controlled autoimmune anemia or thrombocytopenia
- Poorly controlled gastrointestinal disorders or other systemic diseases
- Cancer diagnosis within the past 3 years
- Known allergy to the study drugs or related substances
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants take DZD8586 orally once daily on days 1-28 of each cycle. Starting from cycle 4 day 1, participants also take Venetoclax orally once daily on days 1-28.
Visits occur each cycle for medication administration and monitoring
Duration - 30 days after the last dose for adverse event monitoring, and up to approximately 5 years for progression-free survival assessment
Participants are monitored for safety and disease progression after completing treatment.
Periodic visits for up to 5 years
Trial Site Locations
Total: 15 locations
1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230031
Actively Recruiting
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
3
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Actively Recruiting
4
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
6
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
7
Yichang Central People's Hospital
Yichang, Hubei, China, 443003
Actively Recruiting
8
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
9
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China, 213003
Actively Recruiting
10
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
11
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
12
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130021
Not Yet Recruiting
13
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
14
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
15
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
L
Ling Zhou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here