Clinical Trials

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)


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.

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.

Please refer to this study by its identifier: NCT00865969

Università Di Bologna
Bologna, Italy, 40138
Contact: Pier L Zinzani, MD     
+39 051 6363680    
Principal Investigator: Pier L. Zinzani, MD    

English French German Italian Portuguese Russian Spanish

This is an automatic translation service and therefore the
Cutaneous Lymphoma Foundation is not responsible
for any potential translation inaccuracies.