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

Phase 2

Recruiting

• Conditions: Diffuse Large B-cell Lymphoma (DLBCL)
• Interventions: Drug: abexinostat

• Registration Number: NCT03936153
• Lead Sponsor: Xynomic Pharmaceuticals, Inc.

Brief 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)

Detailed 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)

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-03
• Study Start: 2020-01-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-12-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abexinostat 80 mg bis in die (BID)	abexinostat	Abexinostat 80 mg BID

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Objective Response	up to 56 days	Objective response rate (ORR) as assessed by the investigator
Progression-free survival	Up to 2 years	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.

Trial Locations

Locations (23)

Cancer Center of Guangzhou Medical University; 🇨🇳 Guangzhou, China

The First Affiliate Hospital of Dalian Medical University; 🇨🇳 Dalian, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China

The Affiliated Tumor Hospital of Harbin Medical University; 🇨🇳 Harbin, 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

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, China

Fujian Provincial Cancer Hospital; 🇨🇳 Fuzhou, China

Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University; 🇨🇳 Guangzhou, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, 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

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China

First Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, China