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Clinical Trials in China / NCT03936153
Recruiting Phase 2

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

NCT03936153 · tracked via the Priya Life Science China tracker
Sponsor
Xynomic Pharmaceuticals, Inc.
Phase
Phase 2
Started
2020-01-20
Last updated
2025-04-10

Condition(s) studied

Diffuse Large B-cell Lymphoma (DLBCL)

Investigational drug(s) / intervention(s)

abexinostat

abexinostat: abexinostat tablet

Study summary

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
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

More Xynomic Pharmaceuticals, Inc. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03936153 on ClinicalTrials.gov ↗ ← All trials in China