drugset / Trial / NCT07139873

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

NCT07139873

Phase 3 Recruiting 250 enrolled Dizal Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-09-08
Primary completion
2029-01
Completion
2029-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bendamustine Small molecule Intravenous
Subject DZD8586 Unknown 50 mg Oral
Comparator Idelalisib Small molecule Oral
Comparator Rituximab Monoclonal antibody Intravenous