Evaluating oral abexinostat for patients with relapsed or refractory DLBCL

An Open-label, Single-arm, Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Abexinostat as Monotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

This study is testing if an oral medication called abexinostat can help people with relapsed or hard-to-treat diffuse large B-cell lymphoma feel better after trying other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xynomic Pharmaceuticals, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 23 sites (Beijing and 22 other locations)
• Trial ID: NCT03936153 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm, multi-center phase 2 study aimed at assessing the efficacy and safety of abexinostat, an oral histone deacetylase (HDAC) inhibitor, in patients diagnosed with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Participants will receive abexinostat as a monotherapy after having undergone two prior standard therapy lines, including anti-CD20 antibody and cytotoxic therapy. The study will measure the drug's effectiveness and safety profile in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed DLBCL who have received two prior lines of therapy and are unresponsive to their last treatment.

Not a fit: Patients with primary CNS lymphoma or those who have not recovered from previous treatment toxicity 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: Other studies involving HDAC inhibitors have shown promise in treating various cancers, suggesting potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL);
2. Have received only two prior standard therapy lines for diffuse large B-cell lymphoma (DLBCL) including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy;
3. Confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy;
4. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion;
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
6. Meet various hematological, liver and renal function lab parameters.

Exclusion Criteria:

1. Have primary central nervous system (CNS) lymphoma or secondary central nervous system (CNS) infiltration, transformed lymphoma, unclassified B-cell lymphoma with features intermediate between DLBCL and classical Hodgkin's lymphoma (HL), primary effusion lymphoma, plasma lymphoma;
2. Toxicity not yet recovered from previous anti-tumor therapies;
3. Uncontrolled systemic infections or infections requiring intravenous antibiotics;
4. Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol;
5. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug;
6. Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol;
7. Presence of active graft-versus-host reaction;
8. Have undergone a major surgery within the last month;
9. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection;
10. Have any cardiac impairment as defined per protocol;
11. Have prior history of malignancies other than diffuse large B-cell lymphoma (DLBCL).

Where this trial is running

Beijing and 22 other locations

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
• China-Japan Friendship Hospital — Beijing, China (Recruiting)
• Peking University Third Hospital — Beijing, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, China (Recruiting)
• The First Affiliate Hospital of Dalian Medical University — Dalian, China (Recruiting)
• Fujian Medical University Union Hospital — Fuzhou, China (Recruiting)
• Fujian Provincial Cancer Hospital — Fuzhou, China (Recruiting)
• Cancer Center of Guangzhou Medical University — Guangzhou, China (Recruiting)
• Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University — Guangzhou, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, China (Recruiting)
• The Affiliated Tumor Hospital of Harbin Medical University — Harbin, China (Recruiting)
• The First Hospital of Lanzhou University — Lanzhou, China (Recruiting)
• Linyi Cancer Hospital — Linyi, China (Recruiting)
• Nantong Tumor Hospital — Nantong, China (Recruiting)
• Shanghai Jiao Tong University School Medicine — Shanghai, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
• Second People's Hospital of Shenzhen — Shenzhen, China (Recruiting)
• The Forth Hospital of Hebei Medical University — Shijiazhuang, China (Recruiting)
• First Hospital of Shanxi Medical University — Taiyuan, China (Recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (Recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)

Study contacts

• Principal investigator: Yuankai SHI, Prof — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Bing Zhao, MD

Conditions Diffuse Large B-cell Lymphoma