Treatment for patients with relapsed or refractory diffuse large B-cell lymphoma

A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

This study is testing a new drug called DZD8586 to see if it can help people with diffuse large B-cell lymphoma whose cancer has come back or didn't respond to other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dizal Pharmaceuticals (Industry-sponsored)
• Locations: 16 sites (Hefei, Anhui and 15 other locations)
• Trial ID: NCT06539195 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of DZD8586 as a monotherapy in patients with diffuse large B-cell lymphoma (DLBCL) whose disease has returned or is resistant to previous treatments. The study aims to assess the anti-tumor activity of the drug, monitor potential side effects, and measure drug levels in the body. Participants will be closely monitored to gather data on the drug's performance and safety profile.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed recurrent or refractory DLBCL and adequate organ function.

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 DLBCL.

How similar studies have performed: While this approach is being explored, the specific use of DZD8586 in this context is novel and has not been extensively tested in prior studies.

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. Histologically confirmed recurrent or refractory DLBCL.
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
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. 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 15 other locations

• Research Site — Hefei, Anhui, China (Recruiting)
• Research Site — Beijing, Beijing, China (Recruiting)
• Research Site — Guangzhou, Guangdong, China (Recruiting)
• Research Site — Nanning, Guangxi, China (Recruiting)
• Research Site — Zhengzhou, Henan, China (Recruiting)
• Research Site — Wuhan, Hubei, China (Recruiting)
• Research Site — Changsha, Hunan, China (Recruiting)
• Research Site — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Research Site — Dalian, Liaoning, China (Not_yet_recruiting)
• Research Site — Jinan, Shandong, China (Recruiting)
• Research Site — Linyi, Shandong, China (Not_yet_recruiting)
• Research Site — Xi'an, Shanxi, China (Recruiting)
• Research Site — Chengdu, Sichuan, 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, China (Recruiting)
• Research Site — Tianjin, Tianjin, China (Recruiting)
• Research Site — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Lugui Qiu — National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
• Study coordinator: Ziyi Liu

Conditions Diffuse Large B Cell Lymphoma