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

NCT07139873 | Recruiting Phase 3 DMC

• 1 other identifier: DZ2024B0002
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Approximately 36 Months

Secondary Outcomes (2)

• PFS assessed by investigator

  Approximately 36 Months

• Objective response rate (ORR) by IRC and investigator

  Approximately 36 Months

Study Arms (2)

Daily dose of DZD8586 (Birelentinib)

EXPERIMENTAL

Drug: DZD8586

Investigator's choice

ACTIVE COMPARATOR

Drug: Bendamustine; Drug: Idelalisib; Drug: Rituximab

Interventions

Idelalisib DRUG

Administered orally

Investigator's choice

Rituximab DRUG

Administered intravenously

Investigator's choice

DZD8586 DRUG

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

Also known as: Birelentinib

Daily dose of DZD8586 (Birelentinib)

Bendamustine DRUG

Administered intravenously

Investigator's choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants ≥ 18 years of age.
• ECOG performance status 0-2.
• Confirmed diagnosis of relapsed or refractory CLL/SLL with indication for treatment.
• Adequate bone marrow reserve and organ system functions.
• Participants willing to comply with contraceptive restrictions.

You may not qualify if:

• Any unresolved \> Grade 1 adverse event at the time of starting study treatment.
• Known or suspected Richter transformation.
• Known or suspected CNS involvement.
• Participants with major cardiovascular disease, active infection, malignancy or uncontrolled systemic disease.
• Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
• Women who are breast feeding.
• History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.

Sponsors & Collaborators

• Dizal (Jiangsu) Pharmaceutical Co., Ltd.: lead

Study Sites (2)

First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Nanjing, Jiangsu, China

RECRUITING

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

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Bendamustine Hydrochloride; idelalisib; Rituximab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Director

  Dizal (Jiangsu) Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Frank Fang

CONTACT

0086-21-61095801; frank.fang@dizalpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)