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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)

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ClinicalTrials.gov Identifier: NCT03936153
Recruitment Status : Not yet recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Xynomic Pharmaceuticals, Inc.

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
Diffuse Large B-cell Lymphoma (DLBCL) Drug: abexinostat 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)

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Study Type : Interventional  (Clinical Trial)
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)
Estimated Study Start Date : July 30, 2019
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Abexinostat 80 mg bis in die (BID)
Abexinostat 80 mg BID
Drug: abexinostat
abexinostat tablet




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.



Information from the National Library of Medicine

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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936153


Contacts
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Contact: Bing Zhao, MD (01186)13716386801 bing.zhao@xynomicpharma.com
Contact: Sophia Paspal, PhD RAC 610-405-5974 sophia.paspal@xynomicpharma.com

Sponsors and Collaborators
Xynomic Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Yuankai SHI, Prof Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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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: May 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Abexinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action