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

Launched by XYNOMIC PHARMACEUTICALS, INC. · Apr 30, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a medication called abexinostat, which is taken by mouth, to see how well it works and how safe it is for patients with follicular lymphoma that has come back or not responded to previous treatments. The trial is currently recruiting patients aged 65 to 74, and both men and women can participate. To be eligible, patients must have a confirmed diagnosis of follicular lymphoma, have received at least two prior treatments that included specific types of therapies, and must have stable or worsening disease after their last treatment.

Participants in this trial can expect to take the medication and be monitored for its effects on their lymphoma. It’s important to note that there are certain conditions that would exclude someone from participating, such as having a more aggressive form of lymphoma, recent serious infections, or specific health issues that could interfere with taking the medication. This study aims to provide more information about how effective abexinostat is in treating this type of lymphoma, which could help improve future treatment options for patients.

Gender

ALL

Eligibility 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