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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

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

Clinicaltrials.gov identifier NCT03936153

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted June 16, 2020

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:Diffuse Large B-cell Lymphoma (DLBCL)
  • Intervention/Treatment: Drug: abexinostat
  • 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
  • Estimated Enrollment: 170 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: A 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: January 2020
  • Estimated Primary Completion Date: May 2023
  • Estimated Study Completion Date: May 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) [ 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 Outcome Measures: 1. Objective Response [ Time Frame: up to 56 days ]
    Objective response rate (ORR) as assessed by the investigator
  • 2. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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).

Contacts and Locations
Contacts

Contact: Bing Zhao, MD (01186)13716386801 bing.zhao@xynomicpharma.com

Contact: Sophia Paspal, PhD RAC 610-405-5974 sophia.paspal@xynomicpharma.com

Locations
Show 23 Study Locations
Sponsors and Collaborators

Xynomic Pharmaceuticals, Inc.

Investigators

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

More Information
  • Responsible Party: Xynomic Pharmaceuticals, Inc.
  • ClinicalTrials.gov Identifier: NCT03936153 History of Changes
  • Other Study ID Numbers: XYN-606
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: June 16, 2020
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • 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