Recruiting NCT07154264
A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DZD8586, Venetoclax.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2 Study of DZD8586 Combination Therapy in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)
Overview
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.
Interventions
- Drug DZD8586
DZD8586 will be taken orally once daily on days 1-28 of each cycle. - Drug Venetoclax
Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.
Primary outcome measures
- Part A: Incidence of Adverse Events [Time frame: 30 days after the last dose]
- Part B: 2-year progression free survival (PFS) rate assessed by investigator [Time frame: Approximately 5 years]
Secondary outcome measures (4)
- Part A: PFS assessed by investigator [Time frame: Approximately 5 years]
- Part A: Objective response rate (ORR) assessed by investigator [Time frame: Approximately 5 years]
- Part B: ORR assessed by investigator [Time frame: Approximately 5 years]
- Part B: Incidence of Adverse Events [Time frame: 30 days after the last dose]
Eligibility criteria
Inclusion criteria
- Male and female ≥ 18 years of age.
- ECOG performance status 0-2, and life expectancy ≥ 6 months.
- Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.
- Patients with SLL must have at least one measurable lesion.
- Adequate bone marrow reserve and organ functions.
- Willing to comply with contraceptive restrictions.
Exclusion criteria
- Any of previous or current treatment prohibited by protocol.
- Any unresolved > grade 1 drug-related adverse events.
- Known or suspected Richter's transformation, or prolymphocytic leukemia.
- CNS involvement.
- Active infection.
- Any of severe cardiac or pulmonary abnormalities.
- Poorly controlled autoimmune anemia or autoimmune thrombocytopenia.
- Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
- Prior malignancy within the past 3 years.
- Known allergy to study drugs, any of the ingredients of the study drugs, or xanthine oxidase inhibitors or rasburicase.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 15 centers
- Anhui Provincial Cancer Hospital — Hefei
- Peking University Third Hospital — Beijing
- Zhujiang Hospital of Southern Medical University — Guangzhou
- Nanfang Hospital, Southern Medical University — Guangzhou
- Henan Cancer Hospital — Zhengzhou
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
- Yichang Central People's Hospital — Yichang
- Hunan Cancer Hospital — Changsha
- … and 7 more centers
Identifiers
NCT: NCT07154264 · DZ2025B0001