Clinical trial NCT03936153: Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma (DLBCL)
Lead sponsor: Xynomic Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-03
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single arm treatment group
Primary purpose: TREATMENT

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)

Eligibility criteria: 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).

Primary outcomes:
measure: Clinical effect by evaluating the objective response rate (ORR)
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: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Dalian
country: China
facility: The First Affiliate Hospital of Dalian Medical University
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Fuzhou
country: China
facility: Fujian Provincial Cancer 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: 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 Jiao Tong University School Medicine
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shenzhen
country: China
facility: Second People's Hospital of Shenzhen
city: Shijiazhuang
country: China
facility: The Forth Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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: