DZD8586 compared with doctor’s choice treatments for relapsed/refractory CLL/SLL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, open-label, randomized, multicenter trial randomizing about 250 adults with relapsed or refractory CLL/SLL to receive DZD8586 or investigator's choice therapy (options include bendamustine, idelalisib, or rituximab). The primary endpoint is progression-free survival reviewed by an independent review committee, with safety and tolerability monitored across arms. Key eligibility includes age ≥18, ECOG 0–2, adequate marrow and organ function, and no Richter transformation or CNS involvement. The study is being conducted at major hospitals in Nanjing and Tianjin, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• 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

Study contacts

• Study coordinator: Cong Wei
• Email: Cong.Wei@dizalpharma.com
• Phone: 0086-21-61097873

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.