Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

• Status: Completed
• Trial end date: 2014-10-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc
• Collaborator: Onxeo
• Treatments: Belinostat; Histone Deacetylase Inhibitors

Criteria

Inclusion criteria:

• A histologically confirmed diagnosis of PTCL

• Participants 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.

• Participants 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:

• Relapse within 100 days of autologous or allogeneic bone marrow transplant.

• Prior histone deacetylase (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 human immunodeficiency virus (HIV), hepatitis B or hepatitis C.