RecruitingRecruiting
A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)
NCT07139873 · Dizal Pharmaceuticals
In plain English
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Official title
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
About this study
This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD8586 versus investigator's choice in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma who have progressed following prior therapy.
Primary objective of this study is to assess the efficacy using progression free survival assessed by independent review committee as primary endpoint. Approximately 250 participants are estimated to be randomized into the study.
Eligibility criteria
Inclusion Criteria:
1. Male and female participants ≥ 18 years of age.
2. ECOG performance status 0-2.
3. Confirmed diagnosis of relapsed or refractory CLL/SLL with indication for treatment.
4. Adequate bone marrow reserve and organ system functions.
5. Participants willing to comply with contraceptive restrictions.
Exclusion Criteria:
1. Any unresolved \> Grade 1 adverse event at the time of starting study treatment.
2. Known or suspected Richter transformation.
3. Known or suspected CNS involvement.
4. Previous or current therapy and comedications meet exclusion criteria.
5. Participants with major cardiovascular disease, active infection, malignancy or uncontrolled systemic disease.
6. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
7. Women who are breast feeding.
8. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
Study design
Enrollment target: 250 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-08
Estimated completion: 2029-12
Last updated: 2026-06-03
Interventions
Drug: DZD8586Drug: BendamustineDrug: IdelalisibDrug: Rituximab
Primary outcomes
- • Progression free survival (PFS) assessed by Independent Review Committee (IRC) (Approximately 36 Months)
Sponsor
Dizal Pharmaceuticals · industry
Contacts & investigators
ContactCong Wei · contact · Cong.Wei@dizalpharma.com · 0086-21-61097873
InvestigatorStudy Director · study_director, Dizal Pharmaceutical Co., Ltd.
All locations (2)
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province HospitalRecruiting
Nanjing, Jiangsu, China
National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical CollegeRecruiting
Tianjin, Tianjin Municipality, China