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

NCT07139873 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Interventions

DRUG

DZD8586

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

DRUG

Bendamustine

Administered intravenously

DRUG

Idelalisib

Administered orally

DRUG

Rituximab

Administered intravenously

Sponsors & Collaborators

  • Dizal (Jiangsu) Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Study Director · Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2029-01-31
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07139873 on ClinicalTrials.gov