A Phase 3 Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)
Not Applicable
Not yet recruiting
- Conditions
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Interventions
- Registration Number
- NCT07139873
- Lead Sponsor
- Dizal (Jiangsu) Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
- Male and female participants ≥ 18 years of age.
- ECOG performance status 0-2.
- Confirmed diagnosis of relapsed or refractory CLL/SLL with indication for treatment.
- Adequate bone marrow reserve and organ system functions.
- Participants willing to comply with contraceptive restrictions.
Exclusion Criteria
- Any unresolved > Grade 1 adverse event at the time of starting study treatment.
- Known or suspected Richter transformation.
- Known or suspected CNS involvement.
- Previous or current therapy and comedications meet exclusion criteria.
- Participants with major cardiovascular disease, active infection, malignancy or uncontrolled systemic disease.
- Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
- Women who are breast feeding.
- History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daily dose of DZD8586 (Birelentinib) DZD8586 - Investigator's choice Bendamustine - Investigator's choice Idelalisib - Investigator's choice Rituximab -
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) assessed by Independent Review Committee (IRC) Approximately 36 Months
- Secondary Outcome Measures
Name Time Method PFS assessed by investigator Approximately 36 Months Objective response rate (ORR) by IRC and investigator Approximately 36 Months