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Active, not recruiting Phase 2

A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

NCT03934567 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2020-04-22
Last updated
2025-04-10

Condition(s) studied

Lymphoma, Follicular

Investigational drug(s) / intervention(s)

Abexinostat →

Abexinostat: Abexinostat tablets

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Life expectancy ≥ 3 months 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: 1. Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL) 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

Primary outcome measure(s)

  • Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review — up to 56 days
    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

Trial sites (26)

FacilityCityRegionStatus
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
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 NCT03934567 on ClinicalTrials.gov ↗ ← All trials in China