Phase 2
N=129
Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
Peripheral T-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00865969 ↗Enrolled (actual)
129
Serious AEs
47.3%
Results posted
Sep 2021
Primary outcome: Primary: Objective Response Rate — 25.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Belinostat (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spectrum Pharmaceuticals, Inc
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
25.8 | — |
| SECONDARY Time to Response |
5.6 | — |
| SECONDARY Duration of Response |
13.6 | — |
| SECONDARY Time to Progression |
2 | — |
| SECONDARY Progression Free Survival |
1.6 | — |
| SECONDARY Overall Survival |
7.9 | — |
| SECONDARY Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE) |
61 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00865969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.