Clinical trial · Interventional
Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
NCT00865969CI-TRIAL-00054749PTCLcompletedPhase 2Results postedClinicalTrials.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)
The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.
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 |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belinostat | Drug | Belinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Belinostat
- description
- Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
- interventionNames
- Drug: Belinostat
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 24 months
- description
- Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to International Working Group (IWG) criteria. The response was assessed based on clinical and radiological criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. As pre-defined, the primary endpoint analysis for this study was based on the Independent Review Committee (IRC) assessment of response.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * A histologically confirmed diagnosis of PTCL * Participants must have relapsed or refractory disease after at least one prior systemic anticancer regimen. Systemic anticancer therapy is defined as chemotherapy or immunotherapy administered systemically. * Participants must have at least one site of disease measurable in two dimensions by computed tomography (CT). * Age ≥ 18 years. * Adequate bone marrow, liver, and renal functions. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Negative pregnancy test for women of childbearing potential. Exclusion criteria: * Relapse within 100 days of autologous or allogeneic bone marrow transplant. * Prior histone deacetylase (HDAC) inhibitor therapy. * Co-existing active infection or any medical condition likely to interfere with trial procedures. * Severe cardiovascular disease. * Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies. * Active concurrent malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix). * Symptomatic or untreated central nervous system (CNS) metastases. * Pregnant or breast-feeding women. * Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
References
Publications (1)
- RESULTCampbell P, Thomas CM. Belinostat for the treatment of relapsed or refractory peripheral T-cell lymphoma. J Oncol Pharm Pract. 2017 Mar;23(2):143-147. doi: 10.1177/1078155216634178. Epub 2016 Jun 23. PMID 26921086