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

Sponsor

Xynomic Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03934567

Collaborator

(none)

Enrollment

Locations

Arm

38.2

Anticipated Duration (Months)

3.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Follicular	Drug: Abexinostat	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single Group AssignmentSingle Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Apr 22, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abexinostat 80 mg bis in die (BID) Experimental: Abexinostat 80 mg BID	Drug: Abexinostat Abexinostat tablets

Arm

Intervention/Treatment

Experimental: Abexinostat 80 mg bis in die (BID)

Experimental: Abexinostat 80 mg BID

Drug: Abexinostat

Abexinostat tablets

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Life expectancy ≥ 3 months
Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL)
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)
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
Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI);
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Meet various hematological, liver function and renal function lab parameters

Exclusion Criteria:

Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL)
Current or history of central nervous system (CNS) lymphoma;
Toxicity not yet recovered from previous anti-tumor therapies
Uncontrolled systemic infections or infections requiring intravenous antibiotics
Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors;
Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days
Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug
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
Presence of active graft-versus-host disease
Have undergone a major surgery within 28 days
Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection
Have cardiac impairment as defined per protocol
Have prior history of malignancies other than follicular lymphoma

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	China	100021
2	China-Japan Friendship Hospital	Beijing	China	100029
3	Peking University Third Hospital	Beijing	China	100191
4	Jilin Cancer Hospital	Changchun	China	130012
5	West China Hospital, Sichuan University	Chengdu	China	610041
6	The First Affiliated Hospital of Dalian Medical University	Dalian	China	116011
7	Fujian Medical University Union Hospital	Fuzhou	China	350001
8	Cancer Center of Guangzhou Medical University	Guangzhou	China	510030
9	Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University	Guangzhou	China	510120
10	Nanfang Hospital	Guangzhou	China	510515
11	Hainan General Hospital	Hainan	China	570311
12	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	China	310009
13	Sir Run Run Shaw Hospital, Zhejiang University School of Medical	Hangzhou	China	310020
14	Zhejiang Cancer Hospital	Hangzhou	China	310022
15	The Affiliated Tumor Hospital of Harbin Medical University	Harbin	China	150081
16	The First Hospital of Lanzhou University	Lanzhou	China	730000
17	Linyi Cancer Hospital	Linyi	China	276000
18	Nantong Tumor Hospital	Nantong	China	226361
19	Shanghai Sixth people's hospital	Shanghai	China	200025
20	Fudan University Shanghai Cancer Center	Shanghai	China	200032
21	The Forth Hospital of Hebei Medical University	Shijiazhuang	China	050011
22	Tianjin People's Hospital	Tianjin	China	300000
23	Tianjin Medical University General Hospital	Tianjin	China	300052
24	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	China	221006
25	Henan Cancer Hospital	Zhengzhou	China	450008
26	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	China	450052