A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)
NCT ID: NCT07139873
Last Updated: 2025-11-18
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
PHASE3
250 participants
INTERVENTIONAL
2025-09-08
2029-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Daily dose of DZD8586 (Birelentinib)
DZD8586
Orally, 50 mg, once daily until treatment discontinuation criterion is met.
Investigator's choice
Bendamustine
Administered intravenously
Idelalisib
Administered orally
Rituximab
Administered intravenously
Interventions
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DZD8586
Orally, 50 mg, once daily until treatment discontinuation criterion is met.
Bendamustine
Administered intravenously
Idelalisib
Administered orally
Rituximab
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Known or suspected Richter transformation.
3. Known or suspected CNS involvement.
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.
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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Study Director
Role: STUDY_DIRECTOR
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Locations
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First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China
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
Countries
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Central Contacts
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Other Identifiers
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DZ2024B0002
Identifier Type: -
Identifier Source: org_study_id
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