Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
- Registration Number
- NCT00865969
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Belinostat 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.
- Primary Outcome Measures
Name Time Method Objective Response Rate 24 months Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to International Working Group (IWG) criteria. The response was assessed based on clinical and radiological criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. As pre-defined, the primary endpoint analysis for this study was based on the Independent Review Committee (IRC) assessment of response.
- Secondary Outcome Measures
Name Time Method Overall Survival 24 months Overall Survival was the time from first administration of study treatment until the date of death.
Time to Response 24 months Time to response was defined as the time (in weeks) from first administration of treatment until first response. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.
Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE) 24 months A TEAE was defined as an event with an onset date and time on or after the first dosing start date and time, or on or after the first dosing start date if the onset time was missing. A serious TEAE was any untoward medical occurrence that at any dose results in death, prolonged hospitalization, persistent or significant disability or congenital abnormalities.
Time to Progression 24 months Time to progression was defined as the time (in months) from first administration of treatment to the date of disease progression based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Duration of Response 24 months The Duration of Response was assessed by IWG criteria per the IRC from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. It was estimated by the Kaplan-Meier method. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.
Progression Free Survival 24 months Progression-free survival (PFS) was the duration of time from first administration of study treatment to date of first documented progression or death from any cause. It was based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Trial Locations
- Locations (117)
New York University
🇺🇸New York, New York, United States
Upstate Medical Univeristy Syracuse
🇺🇸Syracuse, New York, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Boca Raton Clinical Research Associates
🇺🇸Boca Raton, Florida, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Erie County Medical Center (Roswell Park)
🇺🇸Buffalo, New York, United States
Kellogg Cancer Care Center
🇺🇸Evanston, Illinois, United States
St Luke's Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
New York University Cancer Institute
🇺🇸New York, New York, United States
Penn State Hershey Cancer Institute
🇺🇸Hershey, Pennsylvania, United States
Klinik Essen Süd, Evangelisches Krankenhaus
🇩🇪Essen, Germany
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Bronx River Medical Associates, PC
🇺🇸Bronx, New York, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Groupe Hospitalier Sud Réunion, Site Saint-Pierre
🇫🇷Saint-Pierre Cedex, France
H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241
🇩🇰Copenhagen, Denmark
Universität Göttingen, Abteilung Hämatologie und Onkologie
🇩🇪Göttingen, Germany
Universitätsmedizin der johannes Gutenberg -Universität Mainz
🇩🇪Mainz, Germany
Hematology Associates
🇺🇸Bedford, Ohio, United States
Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg
🇩🇪Halle, Germany
The Christie NHS Foundation Trust, The Christie Hospital,
🇬🇧Manchester, United Kingdom
Szt István és Szt. Laszlo
🇭🇺Budapest, Hungary
McGill University
🇨🇦Montreal, Canada
Universitätsklinikum Rostock
🇩🇪Rostock, Germany
Complexo Hospitalario a Coruna
🇪🇸A Coruna, Spain
University of Tennessee Cancer Institute
🇺🇸Knoxville, Tennessee, United States
Universitätsklinikum Leipzig AöR
🇩🇪Leipzig, Germany
Hospital Universitario Morales Meseguer
🇪🇸Murcia, Spain
Leitender Oberarzt/Klinik für Onkologie und Hämatologie
🇩🇪Frankfurt, Germany
Belgyógyászati Klinika Györ
🇭🇺Györ, Hungary
Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica
🇮🇹Bologna, Italy
Northern Centre for Cancer Care, Freeman Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
Münchner Studienzentrum Klinikum Rechts der Isar
🇩🇪München, Germany
Tygerberg Hospital, Department of Radiation Oncology
🇿🇦Bellville, South Africa
ICO Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
St James's Institute of Oncology Bexley Wing
🇬🇧Leeds, United Kingdom
Hospital Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Spain
Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital
🇿🇦Pretoria, South Africa
Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands
Małopolskie Centrum Medyczne
🇵🇱Kraków, Poland
Hospital Clinico Universitario de Santiago
🇪🇸A Coruña, Spain
Drs pirjol, Szpak and Moodley Inc.
🇿🇦Durban, South Africa
Hospital Duran i Reinals
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Maranón
🇪🇸Madrid, Spain
Pretoria Academic Hospital, Department of Radiation Oncology
🇿🇦Pretoria, South Africa
Wilshire Oncology Medical Group, Inc
🇺🇸La Verne, California, United States
Comprehensive Cancer Center
🇺🇸Palm Springs, California, United States
Georgia Health Sciences University
🇺🇸Augusta, Georgia, United States
Illinois CancerCare, P.C.
🇺🇸Peoria, Illinois, United States
Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland
🇺🇸Niles, Illinois, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
Monter Cancer Center
🇺🇸Lake Success, New York, United States
Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
🇺🇸Memphis, Tennessee, United States
Cascade Cancer Center
🇺🇸Kirkland, Washington, United States
AZ St. Jan
🇧🇪Brügge, Belgium
University of Liege, Divisions of Hematology and Medical Oncology
🇧🇪Liege, Belgium
Cliniques Universitaires UCL Mont Godinne, Service Hématologie
🇧🇪Yvoir, Belgium
University Medical Center Groningen UMCG, Department of Haematologie
🇳🇱Groningen, Netherlands
Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry
🇬🇧London, United Kingdom
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
UT - M. D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The UT Health Science Centre at San Antonio
🇺🇸San Antonio, Texas, United States
Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Ospedale Policlinico Careggi
🇮🇹Firenze, Italy
ZNA Stuivenberg
🇧🇪Antwerpen, Belgium
Clinique Universitaire Saint Luc, Service Hématologie
🇧🇪Bruxelles, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Avera Cancer Center
🇺🇸Sioux Falls, South Dakota, United States
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
ZNA Middelheim
🇧🇪Antwerpen, Belgium
CHC Zagreb Clinic of Internal Diseases
🇭🇷Zagreb, Croatia
Oncology Associates of Bridgeport
🇺🇸Trumbull, Connecticut, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
CHA Hôpital de l'Enfant-Jésus
🇨🇦Quebec City, Quebec, Canada
CHC Rijeka, Clinic of Internal Diseases
🇭🇷Zagreb, Croatia
Northern New Jersey Cancer Associates
🇺🇸Hackensack, New Jersey, United States
Belgyógyászati Klinika
🇭🇺Debrecen, Hungary
Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii
🇵🇱Gdansk, Poland
Associates In Oncology and Hematology
🇺🇸Chattanooga, Tennessee, United States
CHC Split Clinic of Internal Diseases
🇭🇷Split, Croatia
UH Dubrava Clinic of Internal Diseases
🇭🇷Zagreb, Croatia
Belgyógyászati Klinika es Kardiologial Központ
🇭🇺Szeged, Hungary
Rambam Medical Center Department of Hematology
🇮🇱Haifa, Israel
Hadassah University Hospital Sharet Building Department of Hematology
🇮🇱Jerusalem, Israel
VU Medical Center, Department of Haematology
🇳🇱Amsterdam, Netherlands
Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie
🇵🇱Warszawa, Mazowieckie, Poland
Instytut Hematologii i Transfuzjologii Klinika Hematologii
🇵🇱Warszawa, Poland
State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary
🇷🇺Chelyabinsk, Russian Federation
Narodny Onkologicky Ustav (NOU)
🇸🇰Bratislava, Slovakia
The Soroka University Medical Center
🇮🇱Beer Sheva, Israel
MTZ Clinical Research Sp z o.o.
🇵🇱Warszawa, Poland
Rabin Medical Center Belinson Campus
🇮🇱Petach Tikva, Israel
Isala Clinics, Department of Haematololgy
🇳🇱Zwolle, Netherlands
Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala
🇵🇱Warszawa, Poland
Szpital Wojewódzki w Opolu/Oddział Hematologii
🇵🇱Opole, Poland
Wojewódzki Szpital Specjalistyczny im M. Kopernika w Łodzi Oddział Hematologii - Klinika Hematologii
🇵🇱Łódź, Poland
Klinika Hematologie a Onkohematologie FNLP a LF UPJS
🇸🇰Kosice, Slovakia
Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences
🇷🇺Moscow, Russian Federation
Research Center of Haematology
🇷🇺Moscow, Russian Federation
Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique
🇫🇷Nice, France
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
The Royal Marsden Haemato-Oncology Wards
🇬🇧Sutton, United Kingdom
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Universitätsklinikum des Saarlandes
🇩🇪Homburg/Saar, Germany
University Hospital Marburg
🇩🇪Marburg, Germany
Klinikum Nuernberg Nord
🇩🇪Nuernberg, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Center for Cancers and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Yale Cancer Center-Section of Medical Oncology
🇺🇸New Haven, Connecticut, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States