NCT03936153RecruitingPhase 2
Study to Evaluate Efficacy and Safety of Oral Abexinostat 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)
Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 30 Apr 2019
- Start date
- 20 Jan 2020
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Xynomic Pharmaceuticals, Inc.
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT03936153
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 170
- From 20 Jan 2020 to the primary completion date, 31 Jul 2026
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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).
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The First Affiliate Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Fujian Provincial Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Cancer Center of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sun Yai-Sen Memorial Hospital Sun Yai-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Affiliated Tumor Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| The First Hospital of Lanzhou University Coordinator of this site? Confirm its status | Lanzhou | China | Recruiting |
| LinYi Cancer Hospital Coordinator of this site? Confirm its status | Linyi | China | Recruiting |
| Nantong Tumor Hospital Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
| Shanghai Jiao Tong University School Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Second People's Hospital of Shenzhen Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| The Forth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| First Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.