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)
1 other identifier
interventional
170
1 country
23
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2020
Longer than P75 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2019
CompletedFirst Posted
Study publicly available on registry
May 3, 2019
CompletedStudy Start
First participant enrolled
January 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
April 10, 2025
April 1, 2025
6.5 years
April 30, 2019
April 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical effect by evaluating the objective response rate (ORR)
To evaluate the objective response rate (ORR) of abexinostat in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) as assessed by an independent central imaging review.
up to 56 days
Secondary Outcomes (2)
Objective Response
up to 56 days
Progression-free survival
Up to 2 years
Study Arms (1)
Abexinostat 80 mg bis in die (BID)
EXPERIMENTALAbexinostat 80 mg BID
Interventions
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021, China
China-Japan Friendship Hospital
Beijing, 100029, China
Peking University Third Hospital
Beijing, 100191, China
West China Hospital, Sichuan University
Chengdu, 610041, China
The First Affiliate Hospital of Dalian Medical University
Dalian, 116011, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Fujian Provincial Cancer Hospital
Fuzhou, 350014, China
Cancer Center of Guangzhou Medical University
Guangzhou, 510030, China
Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
Guangzhou, 510120, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, 150081, China
The First Hospital of Lanzhou University
Lanzhou, 730000, China
Linyi Cancer Hospital
Linyi, 276000, China
Nantong Tumor Hospital
Nantong, 226361, China
Shanghai Jiao Tong University School Medicine
Shanghai, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Second People's Hospital of Shenzhen
Shenzhen, China, China
The Forth Hospital of Hebei Medical University
Shijiazhuang, 050011, China
First Hospital of Shanxi Medical University
Taiyuan, 030001, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430000, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221006, China
Henan Cancer Hospital
Zhengzhou, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuankai SHI, Prof
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2019
First Posted
May 3, 2019
Study Start
January 20, 2020
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
April 10, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share