Actively Recruiting
Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Led by Xynomic Pharmaceuticals, Inc. · Updated on 2025-04-10
170
Participants Needed
23
Research Sites
397 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL)
- Received only two prior standard therapy lines for DLBCL including anti-CD20 antibody and cytotoxic therapy
- Disease is unresponsive to the last line of therapy or has progressed after the last line of therapy
- Have at least one measurable lymph node or extranodal lymphoid malignant lesion confirmed by imaging
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Meet required hematological, liver, and renal function laboratory parameters
You will not qualify if you...
- Primary central nervous system (CNS) lymphoma or secondary CNS infiltration
- Transformed lymphoma or unclassified B-cell lymphoma with features between DLBCL and classical Hodgkin's lymphoma
- Primary effusion lymphoma or plasma lymphoma
- Toxicity not recovered from previous anti-tumor therapies
- Uncontrolled systemic infections or infections requiring intravenous antibiotics
- Recent use of steroid hormone, chemotherapy, targeted therapy, radiotherapy, or antibody-based therapies within protocol-specified timeframes
- Unable to swallow tablets or have significant gastrointestinal disorders affecting drug absorption
- Received autologous or allogeneic stem cell transplant within protocol-specified timeframes
- Active graft-versus-host disease
- Major surgery within the last month
- Evidence of HIV or hepatitis C virus infection
- Cardiac impairment as defined in the protocol
- Prior malignancies other than DLBCL
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China, 100021
Actively Recruiting
2
China-Japan Friendship Hospital
Beijing, China, 100029
Actively Recruiting
3
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
4
West China Hospital, Sichuan University
Chengdu, China, 610041
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5
The First Affiliate Hospital of Dalian Medical University
Dalian, China, 116011
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6
Fujian Medical University Union Hospital
Fuzhou, China, 350001
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7
Fujian Provincial Cancer Hospital
Fuzhou, China, 350014
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8
Cancer Center of Guangzhou Medical University
Guangzhou, China, 510030
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9
Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
Guangzhou, China, 510120
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10
Zhejiang Cancer Hospital
Hangzhou, China, 310022
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11
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, China, 150081
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12
The First Hospital of Lanzhou University
Lanzhou, China, 730000
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13
Linyi Cancer Hospital
Linyi, China, 276000
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14
Nantong Tumor Hospital
Nantong, China, 226361
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15
Shanghai Jiao Tong University School Medicine
Shanghai, China, 200025
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16
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
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17
Second People's Hospital of Shenzhen
Shenzhen, China, China
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18
The Forth Hospital of Hebei Medical University
Shijiazhuang, China, 050011
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19
First Hospital of Shanxi Medical University
Taiyuan, China, 030001
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20
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China, 430000
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21
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China, 221006
Actively Recruiting
22
Henan Cancer Hospital
Zhengzhou, China, 450008
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23
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China, 450052
Actively Recruiting
Research Team
B
Bing Zhao, MD
CONTACT
S
Sophia Paspal, PhD RAC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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