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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.
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

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University Third Hospital
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BeijingChinaRecruiting
China-Japan Friendship Hospital
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BeijingChinaRecruiting
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
The First Affiliate Hospital of Dalian Medical University
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DalianChinaRecruiting
Fujian Medical University Union Hospital
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FuzhouChinaRecruiting
Fujian Provincial Cancer Hospital
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FuzhouChinaRecruiting
Cancer Center of Guangzhou Medical University
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GuangzhouChinaRecruiting
Sun Yai-Sen Memorial Hospital Sun Yai-Sen University
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GuangzhouChinaRecruiting
Zhejiang Cancer Hospital
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HangzhouChinaRecruiting
The Affiliated Tumor Hospital of Harbin Medical University
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HarbinChinaRecruiting
The First Hospital of Lanzhou University
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LanzhouChinaRecruiting
LinYi Cancer Hospital
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LinyiChinaRecruiting
Nantong Tumor Hospital
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NantongChinaRecruiting
Shanghai Jiao Tong University School Medicine
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ShanghaiChinaRecruiting
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting
Second People's Hospital of Shenzhen
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ShenzhenChinaRecruiting
The Forth Hospital of Hebei Medical University
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ShijiazhuangChinaRecruiting
First Hospital of Shanxi Medical University
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TaiyuanChinaRecruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaRecruiting
The affiliated hospital of xuzhou medical university
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XuzhouChinaRecruiting
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.