Clinical trial NCT00865969: Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
Official title: A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral T-cell Lymphoma
Keywords: Belinostat
Peripheral T-cell lymphoma
PXD101
PTCL
HDAC inhibitor
Histone deacetylase inhibitor
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Valerio Therapeutics
First posted: 2009-03-20
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: 24 months
Secondary outcomes:
measure: Time to Response
timeFrame: 24 months
measure: Duration of Response
timeFrame: 24 months
measure: Time to Progression
timeFrame: 24 months
measure: Progression Free Survival
timeFrame: 24 months
measure: Overall Survival
timeFrame: 24 months
measure: Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE)
timeFrame: 24 months
Other outcomes:
measure: Population Pharmacokinetics
timeFrame: 24 months
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group, Inc
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center
state: California
city: New Haven
country: United States
facility: Yale Cancer Center-Section of Medical Oncology
state: Connecticut
city: Trumbull
country: United States
facility: Oncology Associates of Bridgeport
state: Connecticut
city: Boca Raton
country: United States
facility: Boca Raton Clinical Research Associates
state: Florida
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: Kellogg Cancer Care Center
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare, P.C.
state: Illinois
city: Bethesda
country: United States
facility: Center for Cancers and Blood Disorders
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Northern New Jersey Cancer Associates
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Bronx
country: United States
facility: Bronx River Medical Associates, PC
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center (Roswell Park)
state: New York
city: Lake Success
country: United States
facility: Monter Cancer Center
state: New York
city: New York
country: United States
facility: New York University Cancer Institute
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Syracuse
country: United States
facility: Upstate Medical Univeristy Syracuse
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Bedford
country: United States
facility: Hematology Associates
state: Ohio
city: Bethlehem
country: United States
facility: St Luke's Cancer Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Cancer Center
state: South Dakota
city: Chattanooga
country: United States
facility: Associates In Oncology and Hematology
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Cancer Institute
state: Tennessee
city: Memphis
country: United States
facility: Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
state: Tennessee
city: Houston
country: United States
facility: UT - M. D. Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: The UT Health Science Centre at San Antonio
state: Texas
city: Richmond
country: United States
facility: Massey Cancer Center
state: Virginia
city: Kirkland
country: United States
facility: Cascade Cancer Center
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
state: Washington
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
city: Bruxelles
country: Belgium
facility: Clinique Universitaire Saint Luc, Service Hématologie
city: Brügge
country: Belgium
facility: AZ St. Jan
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liege
country: Belgium
facility: University of Liege, Divisions of Hematology and Medical Oncology
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL Mont Godinne, Service Hématologie
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Quebec City
country: Canada
facility: CHA Hôpital de l'Enfant-Jésus
state: Quebec
city: Montreal
country: Canada
facility: McGill University
city: Split
country: Croatia
facility: CHC Split Clinic of Internal Diseases
city: Zagreb
country: Croatia
facility: CHC Zagreb Clinic of Internal Diseases
city: Zagreb
country: Croatia
facility: UH Dubrava Clinic of Internal Diseases
city: Zagreb
country: Croatia
facility: CHC Rijeka, Clinic of Internal Diseases
city: Copenhagen
country: Denmark
facility: H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241
city: Nice
country: France
facility: Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique
city: Saint-Pierre Cedex
country: France
facility: Groupe Hospitalier Sud Réunion, Site Saint-Pierre
city: Essen
country: Germany
facility: Klinik Essen Süd, Evangelisches Krankenhaus
city: Frankfurt
country: Germany
facility: Leitender Oberarzt/Klinik für Onkologie und Hämatologie
city: Göttingen
country: Germany
facility: Universität Göttingen, Abteilung Hämatologie und Onkologie
city: Halle
country: Germany
facility: Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
city: Mainz
country: Germany
facility: Universitätsmedizin der johannes Gutenberg -Universität Mainz
city: Marburg
country: Germany
facility: University Hospital Marburg
city: München
country: Germany
facility: Münchner Studienzentrum Klinikum Rechts der Isar
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg Nord
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Budapest
country: Hungary
facility: Szt István és Szt. Laszlo
city: Debrecen
country: Hungary
facility: Belgyógyászati Klinika
city: Györ
country: Hungary
facility: Belgyógyászati Klinika Györ
city: Szeged
country: Hungary
facility: Belgyógyászati Klinika es Kardiologial Központ
city: Beer Sheva
country: Israel
facility: The Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center Department of Hematology
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Sharet Building Department of Hematology
city: Petach Tikva
country: Israel
facility: Rabin Medical Center Belinson Campus
city: Bologna
country: Italy
facility: Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica
city: Firenze
country: Italy
facility: Ospedale Policlinico Careggi
city: Amsterdam
country: Netherlands
facility: VU Medical Center, Department of Haematology
city: Groningen
country: Netherlands
facility: University Medical Center Groningen UMCG, Department of Haematologie
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Zwolle
country: Netherlands
facility: Isala Clinics, Department of Haematololgy
city: Warszawa
country: Poland
facility: Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii
city: Kraków
country: Poland
facility: Małopolskie Centrum Medyczne
city: Opole
country: Poland
facility: Szpital Wojewódzki w Opolu/Oddział Hematologii
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp z o.o.
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii Klinika Hematologii
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala
city: Łódź
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im M. Kopernika w Łodzi Oddział Hematologii - Klinika Hematologii
city: Chelyabinsk
country: Russian Federation
facility: State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary
city: Moscow
country: Russian Federation
facility: Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences
city: Moscow
country: Russian Federation
facility: Research Center of Haematology
city: Bratislava
country: Slovakia
facility: Narodny Onkologicky Ustav (NOU)
city: Kosice
country: Slovakia
facility: Klinika Hematologie a Onkohematologie FNLP a LF UPJS
city: Bellville
country: South Africa
facility: Tygerberg Hospital, Department of Radiation Oncology
city: Durban
country: South Africa
facility: Drs pirjol, Szpak and Moodley Inc.
city: Pretoria
country: South Africa
facility: Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital
city: Pretoria
country: South Africa
facility: Pretoria Academic Hospital, Department of Radiation Oncology
city: A Coruna
country: Spain
facility: Complexo Hospitalario a Coruna
city: A Coruña
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Badalona
country: Spain
facility: ICO Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Duran i Reinals
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranón
city: Murcia
country: Spain
facility: Hospital Universitario Morales Meseguer
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Leeds
country: United Kingdom
facility: St James's Institute of Oncology Bexley Wing
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust, The Christie Hospital,
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Care, Freeman Hospital
city: Sutton
country: United Kingdom
facility: The Royal Marsden Haemato-Oncology Wards
Study officials:
affiliation: H:S Rigshospitalet, Department of Hematology, Denmark
name: Peter Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università di Bologna, Italy
name: Pier L Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques Universitaires UCL Mont Godinne, Belgium
name: André Bosly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liege, Belgium
name: Georges Fillet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Universitaier Saint Luc, Belgium
name: Eric van den Neste, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital de l'Archet 1 Centre Hospitalier Universitaire (CHU) de Nice, France
name: Nicolas Monier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe Hospitalier Sud Réunion, France
name: Elisabeth Perez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: City of Hope National Medical Center, USA
name: Maria Delioukina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center, USA
name: Adam Lerner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pretoria Academic Hospital, South Africa
name: Lydia Dreosti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Drs Pirjol, Szpak and Moodley Inc, Durban, South Africa
name: D. Moodley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen UMCG, The Netherlands
name: Hanneke C. Kluin-Nelemans, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tygerberg Hospital, Cape Town, South Africa
name: G. Sissolak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Isala Clinics, Zwolle, The Netherlands
name: L. Verdonk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VU Medical Center, Amsterdam, The Netherlands
name: O. Visser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University Cancer Institute, USA
name: Owen A. O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University, Department of Oncology Clinical Research Program, Montreal, Canada
name: Sarit Assouline, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICO Hospital Germans Trias i Pujol, Badalona, Spain
name: Juan Manuel Sancho Cia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Central de Asturias, Oviedo, Spain
name: Consolación Rayon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinico Universitario de Santiago, Santiago de Compostella, Spain
name: Sonia Gonzales, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universität Göttingen, Abteilung Hämatologie und Onkologie, Göttingen, Germany
name: Lorenz Trümper, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Ulm, Ulm, Germany
name: Andreas Viardot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany
name: Georg Hess, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg, Halle, Germany
name: Hans-Heinrich Wolf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Marburg, Marburg, Germany
name: Andreas Neubauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cascade Cancer Center
name: Michele Frank, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT - M. D. Anderson Cancer Center
name: Madeleine Duvic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
name: Andrei Shustov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barbara Ann Karmanos Cancer Institute
name: Melissa Runge-Morris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health System
name: Nalini Janakiraman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wasington University School of Medicine- Division of Oncology
name: Amanda Cashen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massey Cancer Center
name: Beata Holkova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hematology Associates
name: Mohammad Tirgan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Upstate Medical Univeristy Syracuse
name: Bernard Poiesz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Morristown Memorial Hospital
name: Charles Farber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erie County Medical Center (Roswell Park)
name: Zale Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Cancers and Blood Disorders
name: Ralph Boccia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kellogg Cancer Care Center
name: David Grinblatt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
name: Laura Blakely, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boca Raton Clinical Research Associates
name: David Dennis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bronx River Medical Associates, PC
name: Fernando Camacho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State Hershey Cancer Institute
name: Eliot Epner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.