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.

ELIGIBILITY
Ages Eligible for Study:  18 Years and older
Genders Eligible for Study:  Both
Accepts Healthy Volunteers:  No

Inclusion criteria include:
•    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.

Exclusion criteria include:
•    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.

CONTACT
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865969

H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241
Copenhagen, Denmark, 2100
Contact: Peter Brown, MD     
+45 35 45 11 28     
peter.brown@rh.regionh.dk    
Principal Investigator: Peter Brown, MD