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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    96
  • sponsor
    Xynomic Pharmaceuticals, Inc.
Updated on 24 May 2021
ct scan
refractory follicular lymphoma

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)

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.

Details
Condition Follicular Lymphoma
Treatment Abexinostat
Clinical Study IdentifierNCT03934567
SponsorXynomic Pharmaceuticals, Inc.
Last Modified on24 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Life expectancy 3 months
Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL)
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)
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
Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Meet various hematological, liver function and renal function lab parameters

Exclusion Criteria

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