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

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

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
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)
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: N/A
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 20, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated 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) [ 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
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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).
Contacts and Locations

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

Locations
Show Show 23 study locations
Sponsors and Collaborators
Xynomic Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Yuankai SHI, Prof Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Tracking Information
First Submitted Date  ICMJE April 30, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date May 12, 2021
Actual Study Start Date  ICMJE January 20, 2020
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Official Title  ICMJE 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)
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
A single arm treatment group
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B-cell Lymphoma (DLBCL)
Intervention  ICMJE Drug: abexinostat
abexinostat tablet
Study Arms  ICMJE Experimental: Abexinostat 80 mg bis in die (BID)
Abexinostat 80 mg BID
Intervention: Drug: abexinostat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2019) 		170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2023
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bing Zhao, MD (01186)13716386801 bing.zhao@xynomicpharma.com
Contact: Sophia Paspal, PhD RAC 610-405-5974 sophia.paspal@xynomicpharma.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936153
Other Study ID Numbers  ICMJE XYN-606
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xynomic Pharmaceuticals, Inc.
Study Sponsor  ICMJE Xynomic Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuankai SHI, Prof Cancer Institute and Hospital, Chinese Academy of Medical Sciences
PRS Account Xynomic Pharmaceuticals, Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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