Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

Completed · Phase 2

Conditions studied: Peripheral T-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT00865969

Run by

Spectrum Pharmaceuticals, Inc

People needed

129

Starts

2008-12-15

Expected to finish

2014-10-27

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Wilshire Oncology Medical Group, Inc — La Verne, California, United States
• Comprehensive Cancer Center — Palm Springs, California, United States
• Yale Cancer Center-Section of Medical Oncology — New Haven, Connecticut, United States
• Oncology Associates of Bridgeport — Trumbull, Connecticut, United States
• Boca Raton Clinical Research Associates — Boca Raton, Florida, United States
• Georgia Health Sciences University — Augusta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Kellogg Cancer Care Center — Evanston, Illinois, United States
• Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland — Niles, Illinois, United States
• Illinois CancerCare, P.C. — Peoria, Illinois, United States
• Center for Cancers and Blood Disorders — Bethesda, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Northern New Jersey Cancer Associates — Hackensack, New Jersey, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Erie County Medical Center (Roswell Park) — Buffalo, New York, United States
• Monter Cancer Center — Lake Success, New York, United States
• New York University Cancer Institute — New York, New York, United States
• New York University — New York, New York, United States
• City of Hope National Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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