Actively Recruiting
A Phase 3, Open-Label, Randomized, Multicenter Study to Evaluate Anti-tumor Efficacy of DZD8586 Versus Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Led by Dizal Pharmaceuticals · Updated on 2026-06-03
250
Participants Needed
2
Research Sites
47 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of DZD8586 compared to treatments chosen by the doctor in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. This phase 3, open-label, randomized, multicenter study aims to measure how well these treatments work in controlling disease progression. Around 250 participants will be enrolled to compare outcomes using progression-free survival as the main measure. Participants will be randomly assigned to receive either DZD8586, taken orally at 50 mg once daily until treatment stops, or the investigator's choice of approved therapies such as Bendamustine, Idelalisib, or Rituximab, administered by intravenous or oral routes. The study does not mask treatments, allowing open observation of effects during the trial period. During the study, participants will be closely monitored through regular assessments over approximately 36 months. Researchers will evaluate progression-free survival by independent review and investigator assessments, along with response rates to treatment. Safety and tolerability will also be tracked to understand the effects of each treatment. The study plans to follow participants until disease progression or other study endpoints are reached.
CONDITIONS
Brief Title
A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants 18 years of age or older
- ECOG performance status between 0 and 2
- Confirmed diagnosis of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma requiring treatment
- Adequate bone marrow reserve and organ function
- Willingness to follow contraceptive restrictions
You will not qualify if you...
- Any unresolved adverse event greater than Grade 1 from previous treatments at the time of starting study treatment
- Known or suspected Richter transformation
- Known or suspected involvement of the central nervous system
- Previous or current therapies or medications that meet exclusion criteria
- Major cardiovascular disease, active infection, other malignancies, or uncontrolled systemic disease
- Uncontrolled nausea, vomiting, chronic gastrointestinal diseases, inability to swallow the study drug, or prior bowel surgery that affects drug absorption
- Women who are breastfeeding
- History of allergic reaction to DZD8586 or similar drugs or ingredients
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 - Up to approximately 36 months
Participants receive either DZD8586 daily or investigator's choice of chemotherapy until treatment discontinuation criteria are met.
Regular visits as per treatment protocol
Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China
Actively Recruiting
2
National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
C
Cong Wei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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