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

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

This study is testing a new drug called DZD8586 to see if it can help people with chronic lymphocytic leukemia or small lymphocytic lymphoma whose cancer has come back or isn’t responding to other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dizal Pharmaceuticals (Industry-sponsored)
• Locations: 17 sites (Hefei, Anhui and 16 other locations)
• Trial ID: NCT06539182 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory CLL/SLL who require treatment.

Not a fit: Patients with central nervous system involvement or those who have undergone recent significant therapies or surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat CLL/SLL.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating CLL/SLL with novel therapies.

Eligibility criteria

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 this trial is running

Hefei, Anhui and 16 other locations

• 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)
• Research Site — Wuhan, Hubei, China (Recruiting)
• First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)
• Research Site — Changchun, Jilin, China (Recruiting)
• Research Site — Dalian, Liaoning, China (Not_yet_recruiting)
• Research Site — Shenyang, Liaoning, China (Recruiting)
• Research Site — Jinan, Shandong, China (Recruiting)
• Research Site — Linyi, Shandong, China (Recruiting)
• Research Site — Shanghai, Shanghai Municipality, China (Recruiting)
• Research Site — Taiyuan, Shangxi, China (Recruiting)
• Research Site — Tianjin, Tianjin Municipality, China (Recruiting)
• Research Site — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jianyong Li — First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
• Study coordinator: Frank Fang

Conditions Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma