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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL);
2. 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;
3. Confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy;
4. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion;
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
6. Meet various hematological, liver and renal function lab parameters.
Exclusion Criteria:
1. 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;
2. Toxicity not yet recovered from previous anti-tumor therapies;
3. Uncontrolled systemic infections or infections requiring intravenous antibiotics;
4. Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol;
5. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug;
6. Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol;
7. Presence of active graft-versus-host reaction;
8. Have undergone a major surgery within the last month;
9. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection;
10. Have any cardiac impairment as defined per protocol;
11. Have prior history of malignancies other than diffuse large B-cell lymphoma (DLBCL).
Primary outcome measure(s)
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.
Trial sites (23)
Facility
City
Region
Status
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
China
Recruiting
China-Japan Friendship Hospital
Beijing
China
Recruiting
Peking University Third Hospital
Beijing
China
Recruiting
West China Hospital, Sichuan University
Chengdu
China
Recruiting
The First Affiliate Hospital of Dalian Medical University
Dalian
China
Recruiting
Fujian Medical University Union Hospital
Fuzhou
China
Recruiting
Fujian Provincial Cancer Hospital
Fuzhou
China
Recruiting
Cancer Center of Guangzhou Medical University
Guangzhou
China
Recruiting
Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
Guangzhou
China
Recruiting
Zhejiang Cancer Hospital
Hangzhou
China
Recruiting
The Affiliated Tumor Hospital of Harbin Medical University
Harbin
China
Recruiting
The First Hospital of Lanzhou University
Lanzhou
China
Recruiting
Linyi Cancer Hospital
Linyi
China
Recruiting
Nantong Tumor Hospital
Nantong
China
Recruiting
Shanghai Jiao Tong University School Medicine
Shanghai
China
Recruiting
Fudan University Shanghai Cancer Center
Shanghai
China
Recruiting
Second People's Hospital of Shenzhen
Shenzhen
China
Recruiting
The Forth Hospital of Hebei Medical University
Shijiazhuang
China
Recruiting
First Hospital of Shanxi Medical University
Taiyuan
China
Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
China
Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
China
Recruiting
Henan Cancer Hospital
Zhengzhou
China
Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
China
Recruiting
More Xynomic Pharmaceuticals, Inc. trials in China
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.
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