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

Overview

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)

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2024

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)

Interventions

  • Drug: abexinostat
    • abexinostat tablet

Arms, Groups and Cohorts

  • Experimental: Abexinostat 80 mg bis in die (BID)
    • Abexinostat 80 mg BID

Clinical Trial Outcome Measures

Primary Measures

  • Clinical effect by evaluating the objective response rate (ORR)
    • Time Frame: 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 Measures

  • Objective Response
    • Time Frame: up to 56 days
    • Objective response rate (ORR) as assessed by the investigator
  • Progression-free survival
    • Time Frame: 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.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xynomic Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yuankai SHI, Prof, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Overall Contact(s)
    • Bing Zhao, MD, (01186)13716386801, bing.zhao@xynomicpharma.com

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