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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00865969
Recruitment Status : Completed
First Posted : March 20, 2009
Last Update Posted : December 8, 2014
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

March 19, 2009
March 20, 2009
December 8, 2014
December 2008
October 2014   (Final data collection date for primary outcome measure)
Primary - Objective response rate [ Time Frame: December 2010 ]
Same as current
Complete list of historical versions of study NCT00865969 on Archive Site
Safety, further efficacy parameters (e.g. time to response, duration of response, time to progression, and survival), and population pharmacokinetics [ Time Frame: December 2010 ]
Same as current
Not Provided
Not Provided
Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
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.

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

Approximately 120 patients will be enrolled. Patients will be treated with 1000 mg/m² 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 IHP revision 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 NCI-CTCAE v. 3.0.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Peripheral T-cell Lymphoma
Drug: PXD101
Belinostat (PXD101) 1000 mg/m²administered as a 30 minute IV infusion on days 1-5 of every 3-week cycle
Other Name: Belinostat
Experimental: Belinostat
Belinostat (PXD101) 1000 mg/m²administered as a 30 minute IV infusion
Intervention: Drug: PXD101
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • 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:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Croatia,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   United Kingdom,   United States
2008-005843-40 ( EudraCT Number )
Not Provided
Not Provided
Spectrum Pharmaceuticals, Inc
Spectrum Pharmaceuticals, Inc
Principal Investigator: Peter Brown, MD H:S Rigshospitalet, Department of Hematology, Denmark
Principal Investigator: Pier L Zinzani, MD Università di Bologna, Italy
Principal Investigator: André Bosly, MD Cliniques Universitaires UCL Mont Godinne, Belgium
Principal Investigator: Georges Fillet, MD University of Liege, Belgium
Principal Investigator: Eric van den Neste, MD Clinique Universitaier Saint Luc, Belgium
Principal Investigator: Nicolas Monier, MD Hôpital de l'Archet 1 Centre Hospitalier Universitaire (CHU) de Nice, France
Principal Investigator: Elisabeth Perez, MD Groupe Hospitalier Sud Réunion, France
Principal Investigator: Maria Delioukina, MD City of Hope National Medical Center, USA
Principal Investigator: Adam Lerner, MD Boston Medical Center, USA
Principal Investigator: Lydia Dreosti, MD Pretoria Academic Hospital, South Africa
Principal Investigator: D. Moodley, MD Drs Pirjol, Szpak and Moodley Inc, Durban, South Africa
Principal Investigator: Hanneke C. Kluin-Nelemans, MD University Medical Center Groningen UMCG, The Netherlands
Principal Investigator: G. Sissolak, MD Tygerberg Hospital, Cape Town, South Africa
Principal Investigator: L. Verdonk, MD Isala Clinics, Zwolle, The Netherlands
Principal Investigator: O. Visser, MD VU Medical Center, Amsterdam, The Netherlands
Principal Investigator: Owen A. O'Connor, MD New York University Cancer Institute, USA
Principal Investigator: Sarit Assouline, MD McGill University, Department of Oncology Clinical Research Program, Montreal, Canada
Principal Investigator: Juan Manuel Sancho Cia, MD ICO Hospital Germans Trias i Pujol, Badalona, Spain
Principal Investigator: Consolación Rayon, MD Hospital Universitario Central de Asturias, Oviedo, Spain
Principal Investigator: Sonia Gonzales, MD Hospital Clinico Universitario de Santiago, Santiago de Compostella, Spain
Principal Investigator: Lorenz Trümper, MD Universität Göttingen, Abteilung Hämatologie und Onkologie, Göttingen, Germany
Principal Investigator: Andreas Viardot, MD Universitätsklinikum Ulm, Ulm, Germany
Principal Investigator: Georg Hess, MD Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany
Principal Investigator: Hans-Heinrich Wolf, MD Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg, Halle, Germany
Principal Investigator: Andreas Neubauer, MD University Hospital Marburg, Marburg, Germany
Principal Investigator: Michele Frank, MD Cascade Cancer Center
Principal Investigator: Madeleine Duvic, MD UT - M. D. Anderson Cancer Center
Principal Investigator: Andrei Shustov, MD Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
Principal Investigator: Melissa Runge-Morris, MD Barbara Ann Karmanos Cancer Institute
Principal Investigator: Nalini Janakiraman, MD Henry Ford Health System
Principal Investigator: Amanda Cashen, MD Wasington University School of Medicine- Division of Oncology
Principal Investigator: Beata Holkova, MD Massey Cancer Center
Principal Investigator: Mohammad Tirgan, MD Hematology Associates
Principal Investigator: Bernard Poiesz, MD Upstate Medical Univeristy Syracuse
Principal Investigator: Charles Farber, MD Morristown Memorial Hospital
Principal Investigator: Zale Bernstein, MD Erie County Medical Center (Roswell Park)
Principal Investigator: Ralph Boccia, MD Center for Cancers and Blood Disorders
Principal Investigator: David Grinblatt, MD Kellogg Cancer Care Center
Principal Investigator: Laura Blakely, MD Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
Principal Investigator: David Dennis, MD Boca Raton Clinical Research Associates
Principal Investigator: Fernando Camacho, MD Bronx River Medical Associates, PC
Principal Investigator: Eliot Epner, MD Penn State Hershey Cancer Institute
Spectrum Pharmaceuticals, Inc
December 2014

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