Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
- Registration Number
- NCT03936153
- Lead Sponsor
- Xynomic Pharmaceuticals, Inc.
- 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)
- Detailed Description
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 diffuse large B-cell lymphoma (DLBCL)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Abexinostat 80 mg bis in die (BID) abexinostat Abexinostat 80 mg BID
- Primary Outcome Measures
Name Time Method Clinical effect by evaluating the objective response rate (ORR) up to 56 days 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.
- 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 (23)
Cancer Center of Guangzhou Medical University
🇨🇳Guangzhou, China
The First Affiliate Hospital of Dalian Medical University
🇨🇳Dalian, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
The Affiliated Tumor Hospital of Harbin Medical University
🇨🇳Harbin, China
Shanghai Jiao Tong University School Medicine
🇨🇳Shanghai, China
Second People's Hospital of Shenzhen
🇨🇳Shenzhen, China
The Forth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, China
China-Japan Friendship Hospital
🇨🇳Beijing, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, China
Fujian Provincial Cancer Hospital
🇨🇳Fuzhou, China
Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
🇨🇳Guangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, China
Linyi Cancer Hospital
🇨🇳Linyi, China
Nantong Tumor Hospital
🇨🇳Nantong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, China