RecruitingPhase 2NCT06539182

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

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


Sponsor

Dizal Pharmaceuticals

Enrollment

155 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called DZD8586 for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) — two closely related blood cancers — that have come back after previous treatments or stopped responding to them. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of CLL or SLL that requires treatment - Your cancer has relapsed (come back) or is refractory (not responding to treatment) - Your blood counts and organ function meet minimum safety levels - You are reasonably functional day-to-day (ECOG 0–2) **You may NOT be eligible if...** - Your leukemia has spread to the brain or spinal fluid, or has transformed into a more aggressive lymphoma (Richter transformation) - You recently had a stem cell transplant, gene therapy, or major surgery (within the past 4–12 weeks depending on treatment type) - You take blood thinners (vitamin K antagonists) - You have had certain recent cancer treatments within specified timeframes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDZD8586

Daily oral dose of DZD8586 at 25 mg.

DRUGDZD8586

Daily oral dose of DZD8586 at 50 mg.

DRUGDZD8586

Daily oral dose of DZD8586 at 75 mg.


Locations(17)

Research Site

Hefei, Anhui, China

Research Site

Beijing, Beijing Municipality, China

Research Site

Beijing, Beijing Municipality, China

Research Site

Guangzhou, Guandong, China

Research Site

Guangzhou, Guandong, China

Research Site

Zhengzhou, Henan, China

Research Site

Wuhan, Hubei, China

First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Nanjing, Jiangsu, China

Research Site

Changchun, Jilin, China

Research Site

Dalian, Liaoning, China

Research Site

Shenyang, Liaoning, China

Research Site

Jinan, Shandong, China

Research Site

Linyi, Shandong, China

Research Site

Shanghai, Shanghai Municipality, China

Research Site

Taiyuan, Shangxi, China

Research Site

Tianjin, Tianjin Municipality, China

Research Site

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06539182


Related Trials