Clinical Trials in China / NCT03934567
Active, not recruiting
Phase 2
A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
NCT03934567 · tracked via the Priya Life Science China tracker
Condition(s) studied
Lymphoma, Follicular
Study 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)
Eligibility
Inclusion Criteria:
1. Life expectancy ≥ 3 months
2. Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL)
3. 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)
4. 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
5. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI);
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
7. Meet various hematological, liver function and renal function lab parameters
Exclusion Criteria:
1. Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL)
2. Current or history of central nervous system (CNS) lymphoma;
3. Toxicity not yet recovered from previous anti-tumor therapies
4. Uncontrolled systemic infections or infections requiring intravenous antibiotics
5. Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors;
6. Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days
7. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug
8. 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
9. Presence of active graft-versus-host disease
10. Have undergone a major surgery within 28 days
11. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection
12. Have cardiac impairment as defined per protocol
13. Have prior history of malignancies other than follicular lymphoma
Primary outcome measure(s)
- 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
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | China | |
| China-Japan Friendship Hospital | Beijing | China | |
| Peking University Third Hospital | Beijing | China | |
| Jilin Cancer Hospital | Changchun | China | |
| West China Hospital, Sichuan University | Chengdu | China | |
| The First Affiliated Hospital of Dalian Medical University | Dalian | China | |
| Fujian Medical University Union Hospital | Fuzhou | China | |
| Cancer Center of Guangzhou Medical University | Guangzhou | China | |
| Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University | Guangzhou | China | |
| Nanfang Hospital | Guangzhou | 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 | |
| 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 |
More Xynomic Pharmaceuticals, Inc. trials in China
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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 NCT03934567 on ClinicalTrials.gov ↗ ← All trials in China