Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
NCT ID: NCT00865969
Last Updated: 2021-10-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2008-12-15
2014-10-27
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Belinostat
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.
Belinostat
Interventions
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Belinostat
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Valerio Therapeutics
INDUSTRY
Spectrum Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Brown, MD
Role: PRINCIPAL_INVESTIGATOR
H:S Rigshospitalet, Department of Hematology, Denmark
Pier L Zinzani, MD
Role: PRINCIPAL_INVESTIGATOR
Università di Bologna, Italy
André Bosly, MD
Role: PRINCIPAL_INVESTIGATOR
Cliniques Universitaires UCL Mont Godinne, Belgium
Georges Fillet, MD
Role: PRINCIPAL_INVESTIGATOR
University of Liege, Belgium
Eric van den Neste, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique Universitaier Saint Luc, Belgium
Nicolas Monier, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital de l'Archet 1 Centre Hospitalier Universitaire (CHU) de Nice, France
Elisabeth Perez, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe Hospitalier Sud Réunion, France
Maria Delioukina, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope National Medical Center, USA
Adam Lerner, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center, USA
Lydia Dreosti, MD
Role: PRINCIPAL_INVESTIGATOR
Pretoria Academic Hospital, South Africa
D. Moodley, MD
Role: PRINCIPAL_INVESTIGATOR
Drs Pirjol, Szpak and Moodley Inc, Durban, South Africa
Hanneke C. Kluin-Nelemans, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen UMCG, The Netherlands
G. Sissolak, MD
Role: PRINCIPAL_INVESTIGATOR
Tygerberg Hospital, Cape Town, South Africa
L. Verdonk, MD
Role: PRINCIPAL_INVESTIGATOR
Isala Clinics, Zwolle, The Netherlands
O. Visser, MD
Role: PRINCIPAL_INVESTIGATOR
VU Medical Center, Amsterdam, The Netherlands
Owen A. O'Connor, MD
Role: PRINCIPAL_INVESTIGATOR
New York University Cancer Institute, USA
Sarit Assouline, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University, Department of Oncology Clinical Research Program, Montreal, Canada
Juan Manuel Sancho Cia, MD
Role: PRINCIPAL_INVESTIGATOR
ICO Hospital Germans Trias i Pujol, Badalona, Spain
Consolación Rayon, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Central de Asturias, Oviedo, Spain
Sonia Gonzales, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinico Universitario de Santiago, Santiago de Compostella, Spain
Lorenz Trümper, MD
Role: PRINCIPAL_INVESTIGATOR
Universität Göttingen, Abteilung Hämatologie und Onkologie, Göttingen, Germany
Andreas Viardot, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Ulm, Ulm, Germany
Georg Hess, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany
Hans-Heinrich Wolf, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg, Halle, Germany
Andreas Neubauer, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Marburg, Marburg, Germany
Michele Frank, MD
Role: PRINCIPAL_INVESTIGATOR
Cascade Cancer Center
Madeleine Duvic, MD
Role: PRINCIPAL_INVESTIGATOR
UT - M. D. Anderson Cancer Center
Andrei Shustov, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
Melissa Runge-Morris, MD
Role: PRINCIPAL_INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Nalini Janakiraman, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Amanda Cashen, MD
Role: PRINCIPAL_INVESTIGATOR
Wasington University School of Medicine- Division of Oncology
Beata Holkova, MD
Role: PRINCIPAL_INVESTIGATOR
Massey Cancer Center
Mohammad Tirgan, MD
Role: PRINCIPAL_INVESTIGATOR
Hematology Associates
Bernard Poiesz, MD
Role: PRINCIPAL_INVESTIGATOR
Upstate Medical Univeristy Syracuse
Charles Farber, MD
Role: PRINCIPAL_INVESTIGATOR
Morristown Memorial Hospital
Zale Bernstein, MD
Role: PRINCIPAL_INVESTIGATOR
Erie County Medical Center (Roswell Park)
Ralph Boccia, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Cancers and Blood Disorders
David Grinblatt, MD
Role: PRINCIPAL_INVESTIGATOR
Kellogg Cancer Care Center
Laura Blakely, MD
Role: PRINCIPAL_INVESTIGATOR
Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
David Dennis, MD
Role: PRINCIPAL_INVESTIGATOR
Boca Raton Clinical Research Associates
Fernando Camacho, MD
Role: PRINCIPAL_INVESTIGATOR
Bronx River Medical Associates, PC
Eliot Epner, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State Hershey Cancer Institute
Locations
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City of Hope National Medical Center
Duarte, California, United States
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
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Upstate Medical Univeristy Syracuse
Syracuse, New York, United States
Bronx River Medical Associates, PC
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Hematology Associates
Bedford, Ohio, United States
St Luke's Cancer Center
Bethlehem, Pennsylvania, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Avera Cancer Center
Sioux Falls, South Dakota, United States
Associates In Oncology and Hematology
Chattanooga, Tennessee, United States
University of Tennessee Cancer Institute
Knoxville, Tennessee, United States
Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
Memphis, Tennessee, United States
UT - M. D. Anderson Cancer Center
Houston, Texas, United States
The UT Health Science Centre at San Antonio
San Antonio, Texas, United States
Massey Cancer Center
Richmond, Virginia, United States
Cascade Cancer Center
Kirkland, Washington, United States
Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
Seattle, Washington, United States
ZNA Middelheim
Antwerp, , Belgium
ZNA Stuivenberg
Antwerp, , Belgium
AZ St. Jan
Bruges, , Belgium
Clinique Universitaire Saint Luc, Service Hématologie
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
University of Liege, Divisions of Hematology and Medical Oncology
Liège, , Belgium
Cliniques Universitaires UCL Mont Godinne, Service Hématologie
Yvoir, , Belgium
University of British Columbia
Vancouver, British Columbia, Canada
CHA Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada
McGill University
Montreal, , Canada
CHC Split Clinic of Internal Diseases
Split, , Croatia
CHC Zagreb Clinic of Internal Diseases
Zagreb, , Croatia
UH Dubrava Clinic of Internal Diseases
Zagreb, , Croatia
CHC Rijeka, Clinic of Internal Diseases
Zagreb, , Croatia
H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241
Copenhagen, , Denmark
Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique
Nice, , France
Groupe Hospitalier Sud Réunion, Site Saint-Pierre
Saint-Pierre, , France
Klinik Essen Süd, Evangelisches Krankenhaus
Essen, , Germany
Leitender Oberarzt/Klinik für Onkologie und Hämatologie
Frankfurt, , Germany
Universität Göttingen, Abteilung Hämatologie und Onkologie
Göttingen, , Germany
Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg
Halle, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, , Germany
Universitätsklinikum Leipzig AöR
Leipzig, , Germany
Universitätsmedizin der johannes Gutenberg -Universität Mainz
Mainz, , Germany
University Hospital Marburg
Marburg, , Germany
Münchner Studienzentrum Klinikum Rechts der Isar
München, , Germany
Klinikum Nuernberg Nord
Nuremberg, , Germany
Universitätsklinikum Rostock
Rostock, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Szt István és Szt. Laszlo
Budapest, , Hungary
Belgyógyászati Klinika
Debrecen, , Hungary
Belgyógyászati Klinika Györ
Győr, , Hungary
Belgyógyászati Klinika es Kardiologial Központ
Szeged, , Hungary
The Soroka University Medical Center
Beersheba, , Israel
Rambam Medical Center Department of Hematology
Haifa, , Israel
Hadassah University Hospital Sharet Building Department of Hematology
Jerusalem, , Israel
Rabin Medical Center Belinson Campus
Petah Tikva, , Israel
Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica
Bologna, , Italy
Ospedale Policlinico Careggi
Florence, , Italy
VU Medical Center, Department of Haematology
Amsterdam, , Netherlands
University Medical Center Groningen UMCG, Department of Haematologie
Groningen, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Isala Clinics, Department of Haematololgy
Zwolle, , Netherlands
Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii
Gdansk, , Poland
Małopolskie Centrum Medyczne
Krakow, , Poland
Wojewódzki Szpital Specjalistyczny im M. Kopernika w Łodzi Oddział Hematologii - Klinika Hematologii
Lodz, , Poland
Szpital Wojewódzki w Opolu/Oddział Hematologii
Opole, , Poland
MTZ Clinical Research Sp z o.o.
Warsaw, , Poland
Instytut Hematologii i Transfuzjologii Klinika Hematologii
Warsaw, , Poland
Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala
Warsaw, , Poland
State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, , Russia
Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences
Moscow, , Russia
Research Center of Haematology
Moscow, , Russia
Narodny Onkologicky Ustav (NOU)
Bratislava, , Slovakia
Klinika Hematologie a Onkohematologie FNLP a LF UPJS
Košice, , Slovakia
Tygerberg Hospital, Department of Radiation Oncology
Bellville, , South Africa
Drs pirjol, Szpak and Moodley Inc.
Durban, , South Africa
Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital
Pretoria, , South Africa
Pretoria Academic Hospital, Department of Radiation Oncology
Pretoria, , South Africa
Complexo Hospitalario a Coruna
A Coruña, , Spain
Hospital Clinico Universitario de Santiago
A Coruña, , Spain
ICO Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Duran i Reinals
Barcelona, , Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, , Spain
Hospital General Universitario Gregorio Maranón
Madrid, , Spain
Hospital Universitario Morales Meseguer
Murcia, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
St James's Institute of Oncology Bexley Wing
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry
London, , United Kingdom
The Christie NHS Foundation Trust, The Christie Hospital,
Manchester, , United Kingdom
Northern Centre for Cancer Care, Freeman Hospital
Newcastle upon Tyne, , United Kingdom
The Royal Marsden Haemato-Oncology Wards
Sutton, , United Kingdom
Countries
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References
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Campbell P, Thomas CM. Belinostat for the treatment of relapsed or refractory peripheral T-cell lymphoma. J Oncol Pharm Pract. 2017 Mar;23(2):143-147. doi: 10.1177/1078155216634178. Epub 2016 Jun 23.
Other Identifiers
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2008-005843-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PXD101-CLN-19
Identifier Type: -
Identifier Source: org_study_id