Clinical Trials in China / NCT03936153
Recruiting
Phase 2
Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
NCT03936153 · tracked via the Priya Life Science China tracker
Condition(s) studied
Diffuse Large B-cell Lymphoma (DLBCL)
Study 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)
Eligibility
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 |
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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 NCT03936153 on ClinicalTrials.gov ↗ ← All trials in China