Clinical trial NCT03934567: A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Lymphoma, Follicular
Keywords: refractory
relapsed
lymph nodes
Lead sponsor: Xynomic Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-02
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review
timeFrame: up to 56 days
Secondary outcomes:
measure: Objective Response
timeFrame: up to 56 days
measure: Progression-free survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Cancer Center of Guangzhou Medical University
city: Guangzhou
country: China
facility: Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Hainan
country: China
facility: Hainan General Hospital
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medical
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: The Affiliated Tumor Hospital of Harbin Medical University
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: Nantong
country: China
facility: Nantong Tumor Hospital
city: Shanghai
country: China
facility: Shanghai Sixth people's hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shijiazhuang
country: China
facility: The Forth Hospital of Hebei Medical University
city: Tianjin
country: China
facility: Tianjin People's Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yuankai SHI, Prof
role: PRINCIPAL_INVESTIGATOR
References: