Clinical trial · Interventional
Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
An Open-label, Single-arm, Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Abexinostat as Monotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
NCT03936153CI-TRIAL-00088386recruitingPhase 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 abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
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 |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
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
- Abexinostat 80 mg BID
- interventionNames
- Drug: abexinostat
Primary outcomes (1)
- measure
- Clinical effect by evaluating the objective response rate (ORR)
- timeFrame
- up to 56 days
- description
- To evaluate the objective response rate (ORR) of abexinostat in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) 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. Histologically confirmed diffuse large B-cell lymphoma (DLBCL); 2. Have received only two prior standard therapy lines for diffuse large B-cell lymphoma (DLBCL) including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy; 3. Confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy; 4. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; 6. Meet various hematological, liver and renal function lab parameters. Exclusion Criteria: 1. Have primary central nervous system (CNS) lymphoma or secondary central nervous system (CNS) infiltration, transformed lymphoma, unclassified B-cell lymphoma with features intermediate between DLBCL and classical Hodgkin's lymphoma (HL), primary effusion lymphoma, plasma lymphoma; 2. Toxicity not yet recovered from previous anti-tumor therapies; 3. Uncontrolled systemic infections or infections requiring intravenous antibiotics; 4. Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol; 5. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug; 6. Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol; 7. Presence of active graft-versus-host reaction; 8. Have undergone a major surgery within the last month; 9. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection; 10. Have any cardiac impairment as defined per protocol; 11. Have prior history of malignancies other than diffuse large B-cell lymphoma (DLBCL).
References
Publications (0)
Data not yet available
No reference posted for this study.