Tests oral abexinostat in adults with relapsed or refractory large B-cell lymphoma
Tests oral abexinostat in adults whose lymphoma returned or did not respond.
Plain-language title generated from the registry record
Registry title: Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Key facts
- Where
- Beijing, Chengdu, Dalian, Fuzhou, Guangzhou, Hangzhou, Harbin, Lanzhou, Linyi, Nantong, Shanghai, Shenzhen, Shijiazhuang, Taiyuan, Wuhan, Xuzhou, and Zhengzhou, ChinaSee the 23 sites
- Phase
- Phase 2
Where in China
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaTaking people
- China-Japan Friendship HospitalBeijing, ChinaTaking people
- Peking University Third HospitalBeijing, ChinaTaking people
- West China Hospital，Sichuan UniversityChengdu, ChinaTaking people
- The First Affiliate Hospital of Dalian Medical UniversityDalian, ChinaTaking people
- Fujian Medical University Union HospitalFuzhou, ChinaTaking people
- Fujian Provincial Cancer HospitalFuzhou, ChinaTaking people
- Cancer Center of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
- Sun Yai-Sen Memorial Hospital Sun Yai-Sen UniversityGuangzhou, ChinaTaking people
- Zhejiang Cancer HospitalHangzhou, ChinaTaking people
- The Affiliated Tumor Hospital of Harbin Medical UniversityHarbin, ChinaTaking people
- The First Hospital of Lanzhou UniversityLanzhou, ChinaTaking people
- LinYi Cancer HospitalLinyi, ChinaTaking people
- Nantong Tumor HospitalNantong, ChinaTaking people
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
- Shanghai Jiao Tong University School MedicineShanghai, ChinaTaking people
- Second People's Hospital of ShenzhenShenzhen, ChinaTaking people
- The Forth Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
- First Hospital of Shanxi Medical UniversityTaiyuan, ChinaTaking people
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
- The affiliated hospital of xuzhou medical universityXuzhou, ChinaTaking people
- Henan Cancer HospitalZhengzhou, ChinaTaking people
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xynomic Pharmaceuticals, Inc.
- Trial code
- NCT03936153
- Record updated
- 10 April 2025
- Original description
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)Read full original descriptionShow less
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)
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)
Inclusion: Histologically confirmed diffuse large B-cell lymphoma (DLBCL); 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; Confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy; Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; Meet various hematological, liver and renal function lab parameters.
Exclusion: Toxicity not yet recovered from previous anti-tumor therapies; Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol; Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol; Have undergone a major surgery within the last month; Uncontrolled systemic infections or infections requiring intravenous antibiotics; Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug; Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection; Have any cardiac impairment as defined per protocol; Have prior history of malignancies other than diffuse large B-cell lymphoma (DLBCL); 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; Presence of active graft-versus-host reaction.