RecruitingPhase 3NCT07139873

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 (Jiangsu) Pharmaceutical Co., Ltd.

Enrollment

250 participants

Start Date

Sep 8, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (TAI-SHAN6) is comparing a new drug called DZD8586 against the doctor's choice of treatment in people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) — slow-growing blood cancers — that has relapsed (come back) or stopped responding to prior treatment. **You may be eligible if...** - You are 18 years or older - You have a confirmed diagnosis of CLL or SLL that has relapsed or is refractory - Your disease requires treatment - Your bone marrow and organ function are adequate - You are willing to follow contraceptive requirements during the study **You may NOT be eligible if...** - You have unresolved significant side effects from prior treatment - Your CLL/SLL has transformed into a more aggressive lymphoma (Richter transformation) - Your cancer has spread to the brain (CNS involvement) - You have major cardiovascular disease, active serious infection, or other uncontrolled conditions - You have swallowing difficulties or chronic gastrointestinal problems that would prevent taking oral medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDZD8586

Orally, 50 mg, once daily until treatment discontinuation criterion is met.

DRUGBendamustine

Administered intravenously

DRUGIdelalisib

Administered orally

DRUGRituximab

Administered intravenously


Locations(2)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07139873


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