Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Recruiting now · Phase 2

Conditions studied: Diffuse Large B-cell Lymphoma (DLBCL)

In brief

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)

Key facts

Study ID

NCT03936153

Run by

Xynomic Pharmaceuticals, Inc.

People needed

170

Starts

2020-01-20

Expected to finish

2027-08-31

Last updated by the study team

2025-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• Toxicity not yet recovered from previous anti-tumor therapies;
• Uncontrolled systemic infections or infections requiring intravenous antibiotics;
• Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol;
• Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug;
• Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol;
• Presence of active graft-versus-host reaction;
• Have undergone a major surgery within the last month;
• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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