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

Spectrum Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Peripheral T-cell Lymphoma

Treatments: Drug: Belinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00865969

2008-005843-40 (EudraCT Number)

PXD101-CLN-19

Details and patient eligibility

About

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.

Full description

This is an open-label, multicenter, single arm efficacy and safety study in participants with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy.

Approximately 120 participants will be enrolled. Participants will be treated with 1000 mg/m^2 belinostat administered as a 30-minute IV infusion on Days 1-5 of every 3-week cycle until there is disease progression or unmanageable treatment-related toxicities.

The primary study endpoint is objective response rate (ORR) based on the International Harmonization Project (IHP) revision International Working Group (IWG) criteria. Safety will be evaluated during the study and for 30 days after the last administration of study drug. Adverse events and laboratory studies will be graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 3.0.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

Belinostat

Experimental group

Description:

Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.

Treatment:

Drug: Belinostat