Clinical trial · Interventional
A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
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)
NCT03934567CI-TRIAL-00088429active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abexinostat | Drug | Abexinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abexinostat 80 mg bis in die (BID)
- description
- Experimental: Abexinostat 80 mg BID
- interventionNames
- Drug: Abexinostat
Primary outcomes (1)
- measure
- Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review
- timeFrame
- up to 56 days
- description
- 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 outcomes (2)
- measure
- Objective Response
- timeFrame
- up to 56 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.