A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)

Sponsor
Dizal Pharmaceuticals
Study ID
NCT07139873
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Idelalisib — DRUG
    Administered orally
  • Rituximab — DRUG
    Administered intravenously
  • DZD8586 — DRUG
    Orally, 50 mg, once daily until treatment discontinuation criterion is met.
  • Bendamustine — DRUG
    Administered intravenously

Study Details

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.

Key Dates

Start date
Sep 8, 2025
Status verified
Jun 2026
Primary completion
Jan 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Daily dose of DZD8586 (Birelentinib)
  • Active Comparator: Investigator's choice

Primary Outcome Measure

Progression free survival (PFS) assessed by Independent Review Committee (IRC) [ Time Frame: Approximately 36 Months ]

Central Contacts

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