A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

Lymphoma, Follicular Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03934567
• Other study ID #: XYN-605
• Status: Recruiting
• Phase: Phase 2
• Start date: April 22, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: Xynomic Pharmaceuticals, Inc.
• Contact: Bing Zhao, MD
• Phone: (01186)13716386801
• Email: bing.zhao[@]xynomicpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

This is an open-label, single-arm, two-stage, multi-center, phase 2 study in patients with relapsed/refractory follicular lymphoma (FL) who have received at least two prior standard therapy lines.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: September 30, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Abexinostat
Abexinostat tablets

Locations

Country	Name	City	State
China	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	Nanfang Hospital	Guangzhou
China	Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University	Guangzhou
China	Hainan General Hospital	Hainan
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medical	Hangzhou
China	The Second Affiliated Hospital Zhejiang University School of Medicine	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	Fudan University Shanghai Cancer Center	Shanghai
China	Shanghai Sixth people's hospital	Shanghai
China	The Forth Hospital of Hebei Medical University	Shijiazhuang
China	Tianjin Medical University General Hospital	Tianjin
China	Tianjin People's 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

Sponsors (1)

Lead Sponsor	Collaborator
Xynomic Pharmaceuticals, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review	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	up to 56 days
Secondary	Objective Response	Objective response rate (ORR) as assessed by the investigator	up to 56 days
Secondary	Progression-free survival	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	Up to 2 years