Trial Details
Spectrum Pharmaceuticals is currently undertaking a study of Belinostat for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)
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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.
Study Type:Interventional
Study Design: Approximately 120 patients will be enrolled in various sites. Patients will be treated with 1000 mg/m² 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
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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Additional Resources
http://www.clinicaltrials.gov/
