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出境医 / 临床实验 / A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

Study Description
Brief Summary:
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 follicular lymphoma (FL)

Condition or disease Intervention/treatment Phase
Lymphoma, Follicular Drug: Abexinostat Phase 2

Detailed Description:
This is an open-label, single-arm, two-stage, multi-center, phase 2 study in patients with relapsed/refractory follicular lymphoma (FL) who have received at least two prior standard therapy lines.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
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 Oral Histone Deacetylase (HDAC)-Inhibitor Abexinostat, as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma (FL)
Actual Study Start Date : April 22, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Abexinostat 80 mg bis in die (BID)
Experimental: Abexinostat 80 mg BID
 Drug: Abexinostat
Abexinostat tablets
Outcome Measures
Primary Outcome Measures :
  1. Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review [ Time Frame: up to 56 days ]
    Objective response rate (ORR), defined as the proportion of patients who have completed response (CR) or partial response (PR) 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. Life expectancy ≥ 3 months
  2. Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL)
  3. Have received at least two prior standard therapy lines including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy for follicular lymphoma (FL)
  4. Confirmed to be unresponsive to the last line of therapy (have stable disease or disease progression during treatment),or have disease progression following the last line of therapy
  5. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI);
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  7. Meet various hematological, liver function and renal function lab parameters

Exclusion Criteria:

  1. Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL)
  2. Current or history of central nervous system (CNS) lymphoma;
  3. Toxicity not yet recovered from previous anti-tumor therapies
  4. Uncontrolled systemic infections or infections requiring intravenous antibiotics
  5. Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors;
  6. Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days
  7. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug
  8. Have received autologous stem cell transplant within 3 months before the first dose, or allogeneic stem cell transplant within 6 months before the first dose
  9. Presence of active graft-versus-host disease
  10. Have undergone a major surgery within 28 days
  11. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection
  12. Have cardiac impairment as defined per protocol
  13. Have prior history of malignancies other than follicular lymphoma
Contacts and Locations

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

Locations
Show Show 24 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 29, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date May 12, 2021
Actual Study Start Date  ICMJE April 22, 2020
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019) 		Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review [ Time Frame: up to 56 days ]
Objective response rate (ORR), defined as the proportion of patients who have completed response (CR) or partial response (PR) as assessed by an Independent Central Imaging Review
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 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 A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
Official Title  ICMJE 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 Follicular Lymphoma (FL)
Brief Summary 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 follicular lymphoma (FL)
Detailed Description This is an open-label, single-arm, two-stage, multi-center, phase 2 study in patients with relapsed/refractory follicular lymphoma (FL) who have received at least two prior standard therapy lines.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Follicular
Intervention  ICMJE Drug: Abexinostat
Abexinostat tablets
Study Arms  ICMJE Experimental: Abexinostat 80 mg bis in die (BID)
Experimental: 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: April 30, 2019) 		96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Life expectancy ≥ 3 months
  2. Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL)
  3. Have received at least two prior standard therapy lines including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy for follicular lymphoma (FL)
  4. Confirmed to be unresponsive to the last line of therapy (have stable disease or disease progression during treatment),or have disease progression following the last line of therapy
  5. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI);
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  7. Meet various hematological, liver function and renal function lab parameters

Exclusion Criteria:

  1. Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL)
  2. Current or history of central nervous system (CNS) lymphoma;
  3. Toxicity not yet recovered from previous anti-tumor therapies
  4. Uncontrolled systemic infections or infections requiring intravenous antibiotics
  5. Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors;
  6. Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days
  7. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug
  8. Have received autologous stem cell transplant within 3 months before the first dose, or allogeneic stem cell transplant within 6 months before the first dose
  9. Presence of active graft-versus-host disease
  10. Have undergone a major surgery within 28 days
  11. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection
  12. Have cardiac impairment as defined per protocol
  13. Have prior history of malignancies other than follicular lymphoma
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, Ph.D. RAC 610-405-5974 sophia.paspal@xynomicpharma.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03934567
Other Study ID Numbers  ICMJE XYN-605
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
Product Manufactured in and Exported from the U.S.: 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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