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

Last updated: April 9, 2025
Sponsor: Xynomic Pharmaceuticals, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Follicular Lymphoma

Lymphoma

Treatment

Abexinostat

Clinical Study ID

NCT03934567
XYN-605
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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 ofdifferentiation antigen (anti-CD20) antibody and cytotoxic therapy for follicularlymphoma (FL)

  4. Confirmed to be unresponsive to the last line of therapy (have stable disease ordisease progression during treatment),or have disease progression following the lastline of therapy

  5. Have at least one radiologically measurable lymph node or extranodal lymphoidmalignant lesion as assessed by computed tomography (CT) or magnetic resonanceimaging (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

Exclusion Criteria:

  1. Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse largeB-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 gastrointestinaldisorders 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 Cvirus (HCV) infection

  12. Have cardiac impairment as defined per protocol

  13. Have prior history of malignancies other than follicular lymphoma

Study Design

Total Participants: 87
Treatment Group(s): 1
Primary Treatment: Abexinostat
Phase: 2
Study Start date:
April 22, 2020
Estimated Completion Date:
October 30, 2025

Study 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.

Connect with a study center

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing, 100029
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, 100191
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun, 130012
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, 610041
    China

    Site Not Available

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, 116011
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, 350001
    China

    Site Not Available

  • Cancer Center of Guangzhou Medical University

    Guangzhou, 510030
    China

    Site Not Available

  • Nanfang Hospital

    Guangzhou, 510515
    China

    Site Not Available

  • Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University

    Guangzhou, 510120
    China

    Site Not Available

  • Hainan General Hospital

    Hainan, 570311
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medical

    Hangzhou, 310020
    China

    Site Not Available

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, 310022
    China

    Site Not Available

  • The Affiliated Tumor Hospital of Harbin Medical University

    Harbin, 150081
    China

    Site Not Available

  • The First Hospital of Lanzhou University

    Lanzhou, 730000
    China

    Site Not Available

  • Linyi Cancer Hospital

    Linyi, 276000
    China

    Site Not Available

  • Nantong Tumor Hospital

    Nantong, 226361
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032
    China

    Site Not Available

  • Shanghai Sixth people's hospital

    Shanghai, 200025
    China

    Site Not Available

  • The Forth Hospital of Hebei Medical University

    Shijiazhuang, 050011
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Site Not Available

  • Tianjin People's Hospital

    Tianjin, 300000
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, 221006
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, 450008
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052
    China

    Site Not Available

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