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NCT Number: NCT07154264

A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)

This is a phase 2 study to investigate the efficacy and safety of DZD8586 in combination in participants with CLL/SLL.

This study consists of two parts: Part A is the safety lead-in phase, and Part B is the dose expansion phase.

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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 2

Primary location

Anhui Provincial Cancer Hospital, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female ≥ 18 years of age.
  • ECOG performance status 0-2, and life expectancy ≥ 6 months.
  • Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.
  • Patients with SLL must have at least one measurable lesion.
  • Adequate bone marrow reserve and organ functions.
  • Willing to comply with contraceptive restrictions.

Exclusion criteria

  • Any of previous or current treatment prohibited by protocol.
  • Any unresolved > grade 1 drug-related adverse events.
  • Known or suspected Richter's transformation, or prolymphocytic leukemia.
  • CNS involvement.
  • Active infection.
  • Any of severe cardiac or pulmonary abnormalities.
  • Poorly controlled autoimmune anemia or autoimmune thrombocytopenia.
  • Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
  • Prior malignancy within the past 3 years.
  • Known allergy to study drugs, any of the ingredients of the study drugs, or xanthine oxidase inhibitors or rasburicase.

Treatment and study plan

DZD8586

Drug

DZD8586 will be taken orally once daily on days 1-28 of each cycle.

Other names: Birelentinib

Venetoclax

Drug

Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.

Primary outcomes

  1. Part A: Incidence of Adverse Events

    Time frame: 30 days after the last dose

  2. Part B: 2-year progression free survival (PFS) rate assessed by investigator

    Time frame: Approximately 5 years

Secondary outcomes

  1. Part A: PFS assessed by investigator

    Time frame: Approximately 5 years

  2. Part A: Objective response rate (ORR) assessed by investigator

    Time frame: Approximately 5 years

  3. Part B: ORR assessed by investigator

    Time frame: Approximately 5 years

  4. Part B: Incidence of Adverse Events

    Time frame: 30 days after the last dose

Study contacts

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

Ling Zhou

CONTACT

[email protected]

0086-21-61095755

Sponsors and collaborators

Lead sponsor

Dizal Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2 Study of DZD8586 Combination Therapy in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Sep 4, 2025
Registry last updated
Jun 22, 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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