Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
Launched by SPECTRUM PHARMACEUTICALS, INC · Mar 19, 2009
Trial Information
Current as of May 23, 2025
Completed
Keywords
ClinConnect Summary
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 Internation...
Gender
ALL
Eligibility 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.
About Spectrum Pharmaceuticals, Inc
Spectrum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development and commercialization of innovative oncology therapies. With a focus on addressing unmet medical needs in cancer treatment, Spectrum leverages advanced research and clinical trials to bring novel therapies to market. The company's commitment to improving patient outcomes is reflected in its robust pipeline of targeted therapies and its strategic collaborations within the healthcare community. Spectrum Pharmaceuticals is dedicated to enhancing the quality of life for patients through cutting-edge science and a patient-centered approach.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Durham, North Carolina, United States
New York, New York, United States
Saint Louis, Missouri, United States
Philadelphia, Pennsylvania, United States
Montreal, Quebec, Canada
Morristown, New Jersey, United States
Chicago, Illinois, United States
Oviedo, , Spain
Duarte, California, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Boston, Massachusetts, United States
Hackensack, New Jersey, United States
New York, New York, United States
Detroit, Michigan, United States
Saint Louis, Missouri, United States
Antwerpen, , Belgium
Palm Springs, California, United States
Gent, , Belgium
Ulm, , Germany
Leicester, , United Kingdom
New York, New York, United States
Antwerpen, , Belgium
Trumbull, Connecticut, United States
El Palmar, , Spain
Murcia, , Spain
Chattanooga, Tennessee, United States
Hamburg, , Germany
Sioux Falls, South Dakota, United States
Kirkland, Washington, United States
Rostock, , Germany
Leipzig, , Germany
Hershey, Pennsylvania, United States
La Verne, California, United States
New Haven, Connecticut, United States
Boca Raton, Florida, United States
Augusta, Georgia, United States
Evanston, Illinois, United States
Niles, Illinois, United States
Peoria, Illinois, United States
Bethesda, Maryland, United States
Bronx, New York, United States
Buffalo, New York, United States
Lake Success, New York, United States
Syracuse, New York, United States
Bedford, Ohio, United States
Bethlehem, Pennsylvania, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Bruxelles, , Belgium
Brügge, , Belgium
Liege, , Belgium
Yvoir, , Belgium
Vancouver, British Columbia, Canada
Quebec City, Quebec, Canada
Montreal, , Canada
Split, , Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Copenhagen, , Denmark
Nice, , France
Saint Pierre Cedex, , France
Essen, , Germany
Frankfurt, , Germany
Göttingen, , Germany
Halle, , Germany
Homburg/Saar, , Germany
Mainz, , Germany
Marburg, , Germany
München, , Germany
Nuernberg, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Györ, , Hungary
Szeged, , Hungary
Beer Sheva, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petach Tikva, , Israel
Bologna, , Italy
Firenze, , Italy
Amsterdam, , Netherlands
Groningen, , Netherlands
Rotterdam, , Netherlands
Zwolle, , Netherlands
Warszawa, Mazowieckie, Poland
Gdansk, , Poland
Kraków, , Poland
Opole, , Poland
Warszawa, , Poland
Warszawa, , Poland
Warszawa, , Poland
łódź, , Poland
Chelyabinsk, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Bratislava, , Slovakia
Kosice, , Slovakia
Bellville, , South Africa
Durban, , South Africa
Pretoria, , South Africa
Pretoria, , South Africa
A Coruna, , Spain
A Coruña, , Spain
Badalona, , Spain
Barcelona, , Spain
Madrid, , Spain
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
Sutton, , United Kingdom
Patients applied
Trial Officials
Peter Brown, MD
Principal Investigator
H:S Rigshospitalet, Department of Hematology, Denmark
Pier L Zinzani, MD
Principal Investigator
Università di Bologna, Italy
André Bosly, MD
Principal Investigator
Cliniques Universitaires UCL Mont Godinne, Belgium
Georges Fillet, MD
Principal Investigator
University of Liege, Belgium
Eric van den Neste, MD
Principal Investigator
Clinique Universitaier Saint Luc, Belgium
Nicolas Monier, MD
Principal Investigator
Hôpital de l'Archet 1 Centre Hospitalier Universitaire (CHU) de Nice, France
Elisabeth Perez, MD
Principal Investigator
Groupe Hospitalier Sud Réunion, France
Maria Delioukina, MD
Principal Investigator
City of Hope National Medical Center, USA
Adam Lerner, MD
Principal Investigator
Boston Medical Center, USA
Lydia Dreosti, MD
Principal Investigator
Pretoria Academic Hospital, South Africa
D. Moodley, MD
Principal Investigator
Drs Pirjol, Szpak and Moodley Inc, Durban, South Africa
Hanneke C. Kluin-Nelemans, MD
Principal Investigator
University Medical Center Groningen UMCG, The Netherlands
G. Sissolak, MD
Principal Investigator
Tygerberg Hospital, Cape Town, South Africa
L. Verdonk, MD
Principal Investigator
Isala Clinics, Zwolle, The Netherlands
O. Visser, MD
Principal Investigator
VU Medical Center, Amsterdam, The Netherlands
Owen A. O'Connor, MD
Principal Investigator
New York University Cancer Institute, USA
Sarit Assouline, MD
Principal Investigator
McGill University, Department of Oncology Clinical Research Program, Montreal, Canada
Juan Manuel Sancho Cia, MD
Principal Investigator
ICO Hospital Germans Trias i Pujol, Badalona, Spain
Consolación Rayon, MD
Principal Investigator
Hospital Universitario Central de Asturias, Oviedo, Spain
Sonia Gonzales, MD
Principal Investigator
Hospital Clinico Universitario de Santiago, Santiago de Compostella, Spain
Lorenz Trümper, MD
Principal Investigator
Universität Göttingen, Abteilung Hämatologie und Onkologie, Göttingen, Germany
Andreas Viardot, MD
Principal Investigator
Universitätsklinikum Ulm, Ulm, Germany
Georg Hess, MD
Principal Investigator
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany
Hans-Heinrich Wolf, MD
Principal Investigator
Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg, Halle, Germany
Andreas Neubauer, MD
Principal Investigator
University Hospital Marburg, Marburg, Germany
Michele Frank, MD
Principal Investigator
Cascade Cancer Center
Madeleine Duvic, MD
Principal Investigator
UT - M. D. Anderson Cancer Center
Andrei Shustov, MD
Principal Investigator
Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
Melissa Runge-Morris, MD
Principal Investigator
Barbara Ann Karmanos Cancer Institute
Nalini Janakiraman, MD
Principal Investigator
Henry Ford Health System
Amanda Cashen, MD
Principal Investigator
Wasington University School of Medicine- Division of Oncology
Beata Holkova, MD
Principal Investigator
Massey Cancer Center
Mohammad Tirgan, MD
Principal Investigator
Hematology Associates
Bernard Poiesz, MD
Principal Investigator
Upstate Medical Univeristy Syracuse
Charles Farber, MD
Principal Investigator
Morristown Memorial Hospital
Zale Bernstein, MD
Principal Investigator
Erie County Medical Center (Roswell Park)
Ralph Boccia, MD
Principal Investigator
Center for Cancers and Blood Disorders
David Grinblatt, MD
Principal Investigator
Kellogg Cancer Care Center
Laura Blakely, MD
Principal Investigator
Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
David Dennis, MD
Principal Investigator
Boca Raton Clinical Research Associates
Fernando Camacho, MD
Principal Investigator
Bronx River Medical Associates, PC
Eliot Epner, MD
Principal Investigator
Penn State Hershey Cancer Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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