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 ClinicalTrials.gov identifier: NCT00865969
Università Di Bologna
Bologna, Italy, 40138
Contact: Pier L Zinzani, MD
+39 051 6363680
Principal Investigator: Pier L. Zinzani, MD