A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
- Registration Number
- NCT03934567
- Lead Sponsor
- Xynomic Pharmaceuticals, Inc.
- 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)
- Detailed Description
This is an open-label, single-arm, two-stage, multi-center, phase 2 study in patients with relapsed/refractory follicular lymphoma (FL) who have received at least two prior standard therapy lines.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 87
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Abexinostat 80 mg bis in die (BID) Abexinostat Experimental: Abexinostat 80 mg BID
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Objective Response up to 56 days Objective response rate (ORR) as assessed by the investigator
Progression-free survival Up to 2 years Progression-free survival (PFS), defined as the time from the initiation of treatment to disease progression or death as assessed by the Independent Central Imaging Review and the investigator
Trial Locations
- Locations (26)
China-Japan Friendship Hospital
🇨🇳Beijing, China
Cancer Center of Guangzhou Medical University
🇨🇳Guangzhou, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, 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
Peking University Third Hospital
🇨🇳Beijing, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Jilin Cancer Hospital
🇨🇳Changchun, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, China
Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
🇨🇳Guangzhou, China
Nanfang Hospital
🇨🇳Guangzhou, 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