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Recruiting NCT06539182

DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)

Phase II Interventional Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DZD8586, DZD8586, DZD8586.
Who it may be relevant to
Registry conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Overview

This study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.

Interventions

  • Drug DZD8586
    Daily oral dose of DZD8586 at 25 mg.
  • Drug DZD8586
    Daily oral dose of DZD8586 at 50 mg.
  • Drug DZD8586
    Daily oral dose of DZD8586 at 75 mg.

Primary outcome measures

  • Objective Response Rate assessed by investigators [Time frame: assessed up to 2 years]
Secondary outcome measures (1)
  • Incidence of adverse event [Time frame: 30 days after the last dose, assessed up to 2 years]

Eligibility criteria

Inclusion criteria

Participants who meet all the following criteria:

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

Exclusion criteria

Participants who meet any of the following criteria:

  • CNS involvement or Richter transformation.
  • Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, monoclonal antibodies and antibody-drug conjugates within 28 days.
  • Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
  • Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.
  • Active infection.
  • Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
  • Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
  • Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
  • Women who are breast feeding.
  • History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 17 centers
  • Research Site — Hefei
  • Research Site — Beijing
  • Research Site — Beijing
  • Research Site — Guangzhou
  • Research Site — Guangzhou
  • Research Site — Zhengzhou
  • Research Site — Wuhan
  • First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital — Nanjing
  • … and 9 more centers

Identifiers

NCT: NCT06539182 · DZ2023B0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗