Treatment for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma

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 clinical trial evaluates the effectiveness of DZD8586 in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose disease has returned or is not responding to previous treatments. The study focuses on assessing the anti-tumor activity of DZD8586 as a standalone therapy, while also monitoring potential side effects and measuring drug levels in the body. Participants must meet specific eligibility criteria, including age and performance status, to ensure safety and efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants who meet all the following criteria:

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

Exclusion Criteria:

Participants who meet any of the following criteria:

1. CNS involvement or Richter transformation.
2. 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.
3. Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
4. 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.
5. Active infection.
6. Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
7. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
8. 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.
9. Women who are breast feeding.
10. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.

Where it's running

• Research Site
  Hefei, Anhui, China Recruiting
• Research Site
  Beijing, Beijing Municipality, China Recruiting
• Research Site
  Beijing, Beijing Municipality, China Recruiting
• Research Site
  Guangzhou, Guandong, China Recruiting
• Research Site
  Guangzhou, Guandong, China Recruiting
• Research Site
  Zhengzhou, Henan, China Recruiting

Study contacts

• Principal investigator: Jianyong Li — First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
• Study coordinator: Tianmo Sun
• Email: Tianmo.Sun@dizalpharma.com
• Phone: 0086-21-61097800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pirtobrutinib for Elderly CLL: See if this BTK inhibitor helps older adults

  This study tests whether pirtobrutinib can help people aged 75 and older with chronic lymphocytic leukemia that hasn’t been treated yet.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07685717

• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

  This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

• DZD8586 plus venetoclax for CLL/SLL

  This will try DZD8586 together with venetoclax in adults with newly diagnosed or treatment‑naïve CLL/SLL who need therapy.

  Recruiting at 14 sites Phase 2 Dizal Pharmaceuticals · Hefei, Anhui and 14 other locations · NCT07154264

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

  This trial will test whether the oral drug DZD8586 works better than commonly chosen treatments for adults with relapsed or refractory CLL/SLL.

  Recruiting at 2 sites Phase 3 Dizal Pharmaceuticals · Nanjing, Jiangsu and 1 other locations · NCT07139873

• LP-168 plus obinutuzumab for previously treated and BTK T474I‑mutated CLL/SLL

  This trial tests whether adding LP-168 to obinutuzumab helps people with previously treated CLL/SLL, including those with the BTK T474I gatekeeper mutation, achieve deeper remissions.

  Recruiting Phase 2 University of Cincinnati · Cincinnati, Ohio · NCT06978088

• Zanubrutinib plus sonrotoclax for relapsed or refractory B‑cell non‑Hodgkin lymphoma in underrepresented racial and ethnic groups

  This phase 1 trial tests whether combining zanubrutinib and sonrotoclax can help adults from underrepresented racial and ethnic groups whose B‑cell non‑Hodgkin lymphoma has returned or not responded to prior treatment.

  Recruiting Phase 1 City of Hope Medical Center · Duarte, California · NCT06859008

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.