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

Primary Purpose

Peripheral T-cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Belinostat
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring Belinostat, Peripheral T-cell lymphoma, PXD101, PTCL, HDAC inhibitor, Histone deacetylase inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope National Medical Center
  • Wilshire Oncology Medical Group, Inc
  • Comprehensive Cancer Center
  • Yale Cancer Center-Section of Medical Oncology
  • Oncology Associates of Bridgeport
  • Boca Raton Clinical Research Associates
  • Georgia Health Sciences University
  • Northwestern University
  • Rush University Medical Center
  • Kellogg Cancer Care Center
  • Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland
  • Illinois CancerCare, P.C.
  • Center for Cancers and Blood Disorders
  • Dana Farber Cancer Institute
  • Boston University Medical Center
  • Karmanos Cancer Institute
  • Henry Ford Health System
  • Saint Louis University
  • Washington University School of Medicine
  • Northern New Jersey Cancer Associates
  • Morristown Memorial Hospital
  • Bronx River Medical Associates, PC
  • Erie County Medical Center (Roswell Park)
  • Monter Cancer Center
  • New York University Cancer Institute
  • New York University
  • Memorial Sloan-Kettering Cancer Center
  • Upstate Medical Univeristy Syracuse
  • Duke University Medical Center
  • Hematology Associates
  • St Luke's Cancer Center
  • Penn State Hershey Cancer Institute
  • Fox Chase Cancer Center
  • Avera Cancer Center
  • Associates In Oncology and Hematology
  • University of Tennessee Cancer Institute
  • Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
  • UT - M. D. Anderson Cancer Center
  • The UT Health Science Centre at San Antonio
  • Massey Cancer Center
  • Cascade Cancer Center
  • Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
  • ZNA Middelheim
  • ZNA Stuivenberg
  • Clinique Universitaire Saint Luc, Service Hématologie
  • AZ St. Jan
  • Universitair Ziekenhuis Gent
  • University of Liege, Divisions of Hematology and Medical Oncology
  • Cliniques Universitaires UCL Mont Godinne, Service Hématologie
  • University of British Columbia
  • CHA Hôpital de l'Enfant-Jésus
  • McGill University
  • CHC Split Clinic of Internal Diseases
  • CHC Zagreb Clinic of Internal Diseases
  • UH Dubrava Clinic of Internal Diseases
  • CHC Rijeka, Clinic of Internal Diseases
  • H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241
  • Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique
  • Groupe Hospitalier Sud Réunion, Site Saint-Pierre
  • Klinik Essen Süd, Evangelisches Krankenhaus
  • Leitender Oberarzt/Klinik für Onkologie und Hämatologie
  • Universität Göttingen, Abteilung Hämatologie und Onkologie
  • Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg
  • Asklepios Klinik St. Georg
  • Universitätsklinikum des Saarlandes
  • Universitätsklinikum Leipzig AöR
  • Universitätsmedizin der johannes Gutenberg -Universität Mainz
  • University Hospital Marburg
  • Münchner Studienzentrum Klinikum Rechts der Isar
  • Klinikum Nuernberg Nord
  • Universitätsklinikum Rostock
  • Universitätsklinikum Ulm
  • Szt István és Szt. Laszlo
  • Belgyógyászati Klinika
  • Belgyógyászati Klinika Györ
  • Belgyógyászati Klinika es Kardiologial Központ
  • The Soroka University Medical Center
  • Rambam Medical Center Department of Hematology
  • Hadassah University Hospital Sharet Building Department of Hematology
  • Rabin Medical Center Belinson Campus
  • Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica
  • Ospedale Policlinico Careggi
  • VU Medical Center, Department of Haematology
  • University Medical Center Groningen UMCG, Department of Haematologie
  • Erasmus University Medical Center
  • Isala Clinics, Department of Haematololgy
  • Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie
  • Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii
  • Małopolskie Centrum Medyczne
  • Szpital Wojewódzki w Opolu/Oddział Hematologii
  • MTZ Clinical Research Sp z o.o.
  • Instytut Hematologii i Transfuzjologii Klinika Hematologii
  • Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala
  • Wojewódzki Szpital Specjalistyczny im M. Kopernika w Łodzi Oddział Hematologii - Klinika Hematologii
  • State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary
  • Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences
  • Research Center of Haematology
  • Narodny Onkologicky Ustav (NOU)
  • Klinika Hematologie a Onkohematologie FNLP a LF UPJS
  • Tygerberg Hospital, Department of Radiation Oncology
  • Drs pirjol, Szpak and Moodley Inc.
  • Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital
  • Pretoria Academic Hospital, Department of Radiation Oncology
  • Complexo Hospitalario a Coruna
  • Hospital Clinico Universitario de Santiago
  • ICO Hospital Germans Trias i Pujol
  • Hospital Duran i Reinals
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital General Universitario Gregorio Maranón
  • Hospital Universitario Morales Meseguer
  • Hospital Universitario Central de Asturias
  • St James's Institute of Oncology Bexley Wing
  • Leicester Royal Infirmary
  • Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry
  • The Christie NHS Foundation Trust, The Christie Hospital,
  • Northern Centre for Cancer Care, Freeman Hospital
  • The Royal Marsden Haemato-Oncology Wards

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Belinostat

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective Response Rate
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

Time to Response
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.
Duration of Response
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.
Time to Progression
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.
Progression Free Survival
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.
Overall Survival
Overall Survival was the time from first administration of study treatment until the date of death.
Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE)
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.

Full Information

First Posted
March 19, 2009
Last Updated
October 14, 2021
Sponsor
Spectrum Pharmaceuticals, Inc
Collaborators
Onxeo
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1. Study Identification

Unique Protocol Identification Number
NCT00865969
Brief Title
Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
Acronym
PTCL
Official Title
A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2008 (Actual)
Primary Completion Date
November 5, 2013 (Actual)
Study Completion Date
October 27, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc
Collaborators
Onxeo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma
Keywords
Belinostat, Peripheral T-cell lymphoma, PXD101, PTCL, HDAC inhibitor, Histone deacetylase inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Belinostat
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Belinostat
Other Intervention Name(s)
PXD101
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Time to Response
Description
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.
Time Frame
24 months
Title
Duration of Response
Description
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.
Time Frame
24 months
Title
Time to Progression
Description
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.
Time Frame
24 months
Title
Progression Free Survival
Description
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.
Time Frame
24 months
Title
Overall Survival
Description
Overall Survival was the time from first administration of study treatment until the date of death.
Time Frame
24 months
Title
Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE)
Description
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 Frame
24 months
Other Pre-specified Outcome Measures:
Title
Population Pharmacokinetics
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Brown, MD
Organizational Affiliation
H:S Rigshospitalet, Department of Hematology, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pier L Zinzani, MD
Organizational Affiliation
Università di Bologna, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
André Bosly, MD
Organizational Affiliation
Cliniques Universitaires UCL Mont Godinne, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georges Fillet, MD
Organizational Affiliation
University of Liege, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric van den Neste, MD
Organizational Affiliation
Clinique Universitaier Saint Luc, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicolas Monier, MD
Organizational Affiliation
Hôpital de l'Archet 1 Centre Hospitalier Universitaire (CHU) de Nice, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elisabeth Perez, MD
Organizational Affiliation
Groupe Hospitalier Sud Réunion, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Delioukina, MD
Organizational Affiliation
City of Hope National Medical Center, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Lerner, MD
Organizational Affiliation
Boston Medical Center, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lydia Dreosti, MD
Organizational Affiliation
Pretoria Academic Hospital, South Africa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
D. Moodley, MD
Organizational Affiliation
Drs Pirjol, Szpak and Moodley Inc, Durban, South Africa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanneke C. Kluin-Nelemans, MD
Organizational Affiliation
University Medical Center Groningen UMCG, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
G. Sissolak, MD
Organizational Affiliation
Tygerberg Hospital, Cape Town, South Africa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
L. Verdonk, MD
Organizational Affiliation
Isala Clinics, Zwolle, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
O. Visser, MD
Organizational Affiliation
VU Medical Center, Amsterdam, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Owen A. O'Connor, MD
Organizational Affiliation
New York University Cancer Institute, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarit Assouline, MD
Organizational Affiliation
McGill University, Department of Oncology Clinical Research Program, Montreal, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan Manuel Sancho Cia, MD
Organizational Affiliation
ICO Hospital Germans Trias i Pujol, Badalona, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Consolación Rayon, MD
Organizational Affiliation
Hospital Universitario Central de Asturias, Oviedo, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sonia Gonzales, MD
Organizational Affiliation
Hospital Clinico Universitario de Santiago, Santiago de Compostella, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lorenz Trümper, MD
Organizational Affiliation
Universität Göttingen, Abteilung Hämatologie und Onkologie, Göttingen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Viardot, MD
Organizational Affiliation
Universitätsklinikum Ulm, Ulm, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georg Hess, MD
Organizational Affiliation
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans-Heinrich Wolf, MD
Organizational Affiliation
Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg, Halle, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Neubauer, MD
Organizational Affiliation
University Hospital Marburg, Marburg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michele Frank, MD
Organizational Affiliation
Cascade Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Madeleine Duvic, MD
Organizational Affiliation
UT - M. D. Anderson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrei Shustov, MD
Organizational Affiliation
Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melissa Runge-Morris, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nalini Janakiraman, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amanda Cashen, MD
Organizational Affiliation
Wasington University School of Medicine- Division of Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beata Holkova, MD
Organizational Affiliation
Massey Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Tirgan, MD
Organizational Affiliation
Hematology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernard Poiesz, MD
Organizational Affiliation
Upstate Medical Univeristy Syracuse
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Farber, MD
Organizational Affiliation
Morristown Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zale Bernstein, MD
Organizational Affiliation
Erie County Medical Center (Roswell Park)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ralph Boccia, MD
Organizational Affiliation
Center for Cancers and Blood Disorders
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Grinblatt, MD
Organizational Affiliation
Kellogg Cancer Care Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Blakely, MD
Organizational Affiliation
Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Dennis, MD
Organizational Affiliation
Boca Raton Clinical Research Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernando Camacho, MD
Organizational Affiliation
Bronx River Medical Associates, PC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eliot Epner, MD
Organizational Affiliation
Penn State Hershey Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Wilshire Oncology Medical Group, Inc
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
Comprehensive Cancer Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Yale Cancer Center-Section of Medical Oncology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Oncology Associates of Bridgeport
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Boca Raton Clinical Research Associates
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
Georgia Health Sciences University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3125
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Kellogg Cancer Care Center
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Illinois CancerCare, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Center for Cancers and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Northern New Jersey Cancer Associates
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Bronx River Medical Associates, PC
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Erie County Medical Center (Roswell Park)
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11067
Country
United States
Facility Name
New York University Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Upstate Medical Univeristy Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Hematology Associates
City
Bedford
State/Province
Ohio
ZIP/Postal Code
44146
Country
United States
Facility Name
St Luke's Cancer Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Penn State Hershey Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Avera Cancer Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Associates In Oncology and Hematology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
University of Tennessee Cancer Institute
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
UT - M. D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The UT Health Science Centre at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0035
Country
United States
Facility Name
Cascade Cancer Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98304
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
ZNA Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Clinique Universitaire Saint Luc, Service Hématologie
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ St. Jan
City
Brügge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University of Liege, Divisions of Hematology and Medical Oncology
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Cliniques Universitaires UCL Mont Godinne, Service Hématologie
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CHA Hôpital de l'Enfant-Jésus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J1Z4
Country
Canada
Facility Name
McGill University
City
Montreal
ZIP/Postal Code
H2W1S6
Country
Canada
Facility Name
CHC Split Clinic of Internal Diseases
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
CHC Zagreb Clinic of Internal Diseases
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
UH Dubrava Clinic of Internal Diseases
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
CHC Rijeka, Clinic of Internal Diseases
City
Zagreb
ZIP/Postal Code
1000
Country
Croatia
Facility Name
H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique
City
Nice
ZIP/Postal Code
6202
Country
France
Facility Name
Groupe Hospitalier Sud Réunion, Site Saint-Pierre
City
Saint-Pierre Cedex
ZIP/Postal Code
97448
Country
France
Facility Name
Klinik Essen Süd, Evangelisches Krankenhaus
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Leitender Oberarzt/Klinik für Onkologie und Hämatologie
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Universität Göttingen, Abteilung Hämatologie und Onkologie
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66424
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsmedizin der johannes Gutenberg -Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
University Hospital Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Münchner Studienzentrum Klinikum Rechts der Isar
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum Nuernberg Nord
City
Nuernberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Universitätsklinikum Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Szt István és Szt. Laszlo
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Belgyógyászati Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Belgyógyászati Klinika Györ
City
Györ
ZIP/Postal Code
9042
Country
Hungary
Facility Name
Belgyógyászati Klinika es Kardiologial Központ
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
The Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medical Center Department of Hematology
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah University Hospital Sharet Building Department of Hematology
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center Belinson Campus
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Policlinico Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
VU Medical Center, Department of Haematology
City
Amsterdam
ZIP/Postal Code
7081 HV
Country
Netherlands
Facility Name
University Medical Center Groningen UMCG, Department of Haematologie
City
Groningen
ZIP/Postal Code
9700
Country
Netherlands
Facility Name
Erasmus University Medical Center
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Isala Clinics, Department of Haematololgy
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Małopolskie Centrum Medyczne
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Szpital Wojewódzki w Opolu/Oddział Hematologii
City
Opole
ZIP/Postal Code
45-051
Country
Poland
Facility Name
MTZ Clinical Research Sp z o.o.
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii Klinika Hematologii
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im M. Kopernika w Łodzi Oddział Hematologii - Klinika Hematologii
City
Łódź
ZIP/Postal Code
93-510
Country
Poland
Facility Name
State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Center of Haematology
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Narodny Onkologicky Ustav (NOU)
City
Bratislava
ZIP/Postal Code
83310
Country
Slovakia
Facility Name
Klinika Hematologie a Onkohematologie FNLP a LF UPJS
City
Kosice
ZIP/Postal Code
04066
Country
Slovakia
Facility Name
Tygerberg Hospital, Department of Radiation Oncology
City
Bellville
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Drs pirjol, Szpak and Moodley Inc.
City
Durban
ZIP/Postal Code
4126
Country
South Africa
Facility Name
Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Pretoria Academic Hospital, Department of Radiation Oncology
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Complexo Hospitalario a Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago
City
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
ICO Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08918
Country
Spain
Facility Name
Hospital Duran i Reinals
City
Barcelona
ZIP/Postal Code
08007
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranón
City
Madrid
ZIP/Postal Code
CP 28007
Country
Spain
Facility Name
Hospital Universitario Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
St James's Institute of Oncology Bexley Wing
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust, The Christie Hospital,
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Northern Centre for Cancer Care, Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
The Royal Marsden Haemato-Oncology Wards
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26921086
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.
Results Reference
result

Learn more about this trial

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

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