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Phase 3Recruiting

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

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

Sponsor
Dizal Pharmaceuticals (Industry)
Enrollment
250 planned
Conditions
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Interventions
DZD8586; Bendamustine; Idelalisib; Rituximab
Ages
adults, older adults
Registry
NCT07139873

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Progression free survival (PFS) assessed by Independent Review Committee (IRC)

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered