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

Sponsor
Xynomic Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03936153
Collaborator
(none)
170
Enrollment
23
Locations
1
Arm
40.3
Anticipated Duration (Months)
7.4
Patients Per Site
0.2
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 abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A single arm treatment groupA single arm treatment group
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 Abexinostat as Monotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Actual Study Start Date :
Jan 20, 2020
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

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

Abexinostat 80 mg BID

Drug: abexinostat
abexinostat tablet

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Objective Response [up to 56 days]

    Objective response rate (ORR) as assessed by the investigator

  2. 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:
No
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).

Contacts and Locations

Locations

Site City State 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 West China Hospital, Sichuan University Chengdu China 610041
5 The First Affiliate Hospital of Dalian Medical University Dalian China 116011
6 Fujian Medical University Union Hospital Fuzhou China 350001
7 Fujian Provincial Cancer Hospital Fuzhou China 350014
8 Cancer Center of Guangzhou Medical University Guangzhou China 510030
9 Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University Guangzhou China 510120
10 Zhejiang Cancer Hospital Hangzhou China 310022
11 The Affiliated Tumor Hospital of Harbin Medical University Harbin China 150081
12 The First Hospital of Lanzhou University Lanzhou China 730000
13 Linyi Cancer Hospital Linyi China 276000
14 Nantong Tumor Hospital Nantong China 226361
15 Shanghai Jiao Tong University School Medicine Shanghai China 200025
16 Fudan University Shanghai Cancer Center Shanghai China 200032
17 Second People's Hospital of Shenzhen Shenzhen China China
18 The Forth Hospital of Hebei Medical University Shijiazhuang China 050011
19 First Hospital of Shanxi Medical University Taiyuan China 030001
20 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan China 430000
21 The Affiliated Hospital of Xuzhou Medical University Xuzhou China 221006
22 Henan Cancer Hospital Zhengzhou China 450008
23 The First Affiliated Hospital of Zhengzhou University Zhengzhou China 450052

Sponsors and Collaborators

  • Xynomic Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Yuankai SHI, Prof, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xynomic Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT03936153
Other Study ID Numbers:
  • XYN-606
First Posted:
May 3, 2019
Last Update Posted:
Sep 2, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Abexinostat

Study Results

No Results Posted as of Sep 2, 2021