A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
NCT ID: NCT03934567
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
87 participants
INTERVENTIONAL
2020-04-22
2025-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Abexinostat 80 mg bis in die (BID)
Experimental: Abexinostat 80 mg BID
Abexinostat
Abexinostat tablets
Interventions
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Abexinostat
Abexinostat tablets
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL)
3. 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)
4. 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
5. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI);
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
7. Meet various hematological, liver function and renal function lab parameters
Exclusion Criteria
2. Current or history of central nervous system (CNS) lymphoma;
3. Toxicity not yet recovered from previous anti-tumor therapies
4. Uncontrolled systemic infections or infections requiring intravenous antibiotics
5. Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors;
6. Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days
7. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug
8. 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
9. Presence of active graft-versus-host disease
10. Have undergone a major surgery within 28 days
11. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection
12. Have cardiac impairment as defined per protocol
13. Have prior history of malignancies other than follicular lymphoma
18 Years
ALL
No
Sponsors
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Xynomic Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yuankai SHI, Prof
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, , China
China-Japan Friendship Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Jilin Cancer Hospital
Changchun, , China
West China Hospital, Sichuan University
Chengdu, , China
The First Affiliated Hospital of Dalian Medical University
Dalian, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Cancer Center of Guangzhou Medical University
Guangzhou, , China
Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
Guangzhou, , China
Nanfang Hospital
Guangzhou, , China
Hainan General Hospital
Hainan, , China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University School of Medical
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, , China
The First Hospital of Lanzhou University
Lanzhou, , China
Linyi Cancer Hospital
Linyi, , China
Nantong Tumor Hospital
Nantong, , China
Shanghai Sixth people's hospital
Shanghai, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
The Forth Hospital of Hebei Medical University
Shijiazhuang, , China
Tianjin People's Hospital
Tianjin, , China
Tianjin Medical University General Hospital
Tianjin, , China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, , China
Henan Cancer Hospital
Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
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Other Identifiers
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XYN-605
Identifier Type: -
Identifier Source: org_study_id
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