Trial Details
A Multicenter, Open-Label Trial of Belinostat in patients with Relapsed or Refractory Peripheral T-Cell Lymphoma.
The BELIEF Trial
Purpose
The purpose of this study is to assess efficacy and safety of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.
The primary study endpoint is objective response rate (ORR) based on the IHP revision IWG criteria (Cheson 2007). Safety will be evaluated during the study and for 30 days after the last administration of study drug.
Study Type:Interventional
Study Design: Approximately 120 patients will be enrolled in various sites. Patients will be treated with 1000 mg/mē belinostat administered as a 30-minute infusion given daily for 5 days every 3 weeks until there is disease progression or unmanageable treatment-related toxicities.
Primary Outcome Measures:
Objective response rate [ORR]
Secondary Outcome Measures:
Safety
Time to Response
Duration of Response [DUR]
Time to Progression [TPP]
Overall Survival [OS]
Intervention Details: Belinostat (PXD101) 1000 mg/mē administered as a 30-minute infusion given daily for 5 days every 3 weeks
Criteria
Inclusion criteria:
- A histologically confirmed diagnosis of PTCL
- Patients 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.
- Patients 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.
- Relapse within 100 days of autologous or allogeneic bone marrow transplant.
- Prior 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 HIV, hepatitis B or hepatitis C.
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