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NCT Number: NCT07139873

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Any unresolved > Grade 1 adverse event at the time of starting study treatment.
  • Known or suspected Richter transformation.
  • Known or suspected CNS involvement.
  • Previous or current therapy and comedications meet exclusion criteria.
  • 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.

Treatment and study plan

DZD8586

Drug

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

Other names: Birelentinib

Bendamustine

Drug

Administered intravenously

idelalisib

Drug

Administered orally

Rituximab

Drug

Administered intravenously

Primary outcomes

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

    Time frame: Approximately 36 Months

Secondary outcomes

  1. PFS assessed by investigator

    Time frame: Approximately 36 Months

  2. Objective response rate (ORR) by IRC and investigator

    Time frame: Approximately 36 Months

Study contacts

Contact information is provided by the study sponsor or research team.

Cong Wei

CONTACT

[email protected]

0086-21-61097873

Sponsors and collaborators

Lead sponsor

Dizal Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 24, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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