A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
An Open-label, Single-arm, Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Oral Histone Deacetylase (HDAC)-Inhibitor Abexinostat, as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma (FL)
1 other identifier
interventional
87
1 country
26
Brief Summary
An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of oral histone deacetylase (HDAC)-inhibitor abexinostat, as monotherapy in patients with relapsed or refractory follicular lymphoma (FL)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2020
Longer than P75 for phase_2
26 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 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 2, 2019
CompletedStudy Start
First participant enrolled
April 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedApril 10, 2025
April 1, 2025
4.8 years
April 29, 2019
April 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review
Objective response rate (ORR), defined as the proportion of patients who have completed response (CR) or partial response (PR) 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)
EXPERIMENTALExperimental: Abexinostat 80 mg BID
Interventions
Eligibility Criteria
You may qualify if:
- Life expectancy ≥ 3 months
- Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL)
- Have received at least two prior standard therapy lines including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy for follicular lymphoma (FL)
- Confirmed to be unresponsive to the last line of therapy (have stable disease or disease progression during treatment),or have disease progression following the last line of therapy
- Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Meet various hematological, liver function and renal function lab parameters
You may not qualify if:
- Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL)
- Current or history of central nervous system (CNS) lymphoma;
- Toxicity not yet recovered from previous anti-tumor therapies
- Uncontrolled systemic infections or infections requiring intravenous antibiotics
- Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors;
- Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days
- Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug
- Have received autologous stem cell transplant within 3 months before the first dose, or allogeneic stem cell transplant within 6 months before the first dose
- Presence of active graft-versus-host disease
- Have undergone a major surgery within 28 days
- Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection
- Have cardiac impairment as defined per protocol
- Have prior history of malignancies other than follicular lymphoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021, China
China-Japan Friendship Hospital
Beijing, 100029, China
Peking University Third Hospital
Beijing, 100191, China
Jilin Cancer Hospital
Changchun, 130012, China
West China Hospital, Sichuan University
Chengdu, 610041, China
The First Affiliated Hospital of Dalian Medical University
Dalian, 116011, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Cancer Center of Guangzhou Medical University
Guangzhou, 510030, China
Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
Guangzhou, 510120, China
Nanfang Hospital
Guangzhou, 510515, China
Hainan General Hospital
Hainan, 570311, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medical
Hangzhou, 310020, 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 Sixth people's hospital
Shanghai, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
The Forth Hospital of Hebei Medical University
Shijiazhuang, 050011, China
Tianjin People's Hospital
Tianjin, 300000, China
Tianjin Medical University General Hospital
Tianjin, 300052, 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
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 29, 2019
First Posted
May 2, 2019
Study Start
April 22, 2020
Primary Completion
January 29, 2025
Study Completion
October 30, 2025
Last Updated
April 10, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share