Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Diffuse Large B-cell Lymphoma (DLBCL) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03936153
• Other study ID #: XYN-606
• Status: Recruiting
• Phase: Phase 2
• Start date: January 20, 2020
• Est. completion date: May 31, 2025

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 abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Description:

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 diffuse large B-cell lymphoma (DLBCL)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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).

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma (DLBCL)
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• abexinostat
abexinostat tablet

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	West China Hospital, Sichuan University	Chengdu
China	The First Affiliate Hospital of Dalian Medical University	Dalian
China	Fujian Medical University Union Hospital	Fuzhou
China	Fujian Provincial Cancer Hospital	Fuzhou
China	Cancer Center of Guangzhou Medical University	Guangzhou
China	Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University	Guangzhou
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 Jiao Tong University School Medicine	Shanghai
China	Second People's Hospital of Shenzhen	Shenzhen
China	The Forth Hospital of Hebei Medical University	Shijiazhuang
China	First Hospital of Shanxi Medical University	Taiyuan
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan
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 by evaluating the objective response rate (ORR)	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.	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