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

Phase 2

Active, not recruiting

• Conditions: Lymphoma, Follicular
• Interventions: Drug: Abexinostat

• Registration Number: NCT03934567
• Lead Sponsor: Xynomic Pharmaceuticals, Inc.

Brief 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)

Detailed 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.

Study Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-02
• Study Start: 2020-04-22
• Primary Completion: 2025-01-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

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 (26)

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

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