Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

NCT00865969 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: PXD101-CLN-192008-005843-40
• Study Type: interventional
• Target: 129
• Locations: 17 countries
• Sites: 117

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.

Conditions

Peripheral T-cell Lymphoma

Keywords

Belinostat; Peripheral T-cell lymphoma; PXD101; PTCL; HDAC inhibitor; Histone deacetylase inhibitor

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (6)

• Time to Response

  24 months

• Duration of Response

  24 months

• Time to Progression

  24 months

• Progression Free Survival

  24 months

• Overall Survival

  24 months

Other Outcomes (1)

• Population Pharmacokinetics

  24 months

Study Arms (1)

Belinostat

EXPERIMENTAL

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.

Drug: Belinostat

Interventions

Belinostat DRUG

Also known as: PXD101

Belinostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead
• Valerio Therapeutics: collaborator

Study Sites (117)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Wilshire Oncology Medical Group, Inc

La Verne, California, 91750, United States

Location

Comprehensive Cancer Center

Palm Springs, California, 92262, United States

Location

Yale Cancer Center-Section of Medical Oncology

New Haven, Connecticut, 06520, United States

Location

Oncology Associates of Bridgeport

Trumbull, Connecticut, 06611, United States

Location

Boca Raton Clinical Research Associates

Boca Raton, Florida, 33432, United States

Location

Georgia Health Sciences University

Augusta, Georgia, 30912-3125, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Kellogg Cancer Care Center

Evanston, Illinois, 60201, United States

Location

Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland

Niles, Illinois, 60714, United States

Location

Illinois CancerCare, P.C.

Peoria, Illinois, 61615, United States

Location

Center for Cancers and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Northern New Jersey Cancer Associates

Hackensack, New Jersey, 07601, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Erie County Medical Center (Roswell Park)

Buffalo, New York, 14215, United States

Location

Monter Cancer Center

Lake Success, New York, 11067, United States

Location

New York University Cancer Institute

New York, New York, 10016, United States

Location

New York University

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Upstate Medical Univeristy Syracuse

Syracuse, New York, 13210, United States

Location

Bronx River Medical Associates, PC

The Bronx, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Hematology Associates

Bedford, Ohio, 44146, United States

Location

St Luke's Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Penn State Hershey Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Avera Cancer Center

Sioux Falls, South Dakota, 57105, United States

Location

Associates In Oncology and Hematology

Chattanooga, Tennessee, 37421, United States

Location

University of Tennessee Cancer Institute

Knoxville, Tennessee, 37920, United States

Location

Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)

Memphis, Tennessee, 38138, United States

Location

UT - M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The UT Health Science Centre at San Antonio

San Antonio, Texas, 78229, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0035, United States

Location

Cascade Cancer Center

Kirkland, Washington, 98304, United States

Location

Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

ZNA Stuivenberg

Antwerp, 2060, Belgium

Location

AZ St. Jan

Bruges, 8000, Belgium

Location

Clinique Universitaire Saint Luc, Service Hématologie

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

University of Liege, Divisions of Hematology and Medical Oncology

Liège, 4000, Belgium

Location

Cliniques Universitaires UCL Mont Godinne, Service Hématologie

Yvoir, 5530, Belgium

Location

University of British Columbia

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CHA Hôpital de l'Enfant-Jésus

Québec, Quebec, G1J1Z4, Canada

Location

McGill University

Montreal, H2W1S6, Canada

Location

CHC Split Clinic of Internal Diseases

Split, 21000, Croatia

Location

CHC Zagreb Clinic of Internal Diseases

Zagreb, 10000, Croatia

Location

UH Dubrava Clinic of Internal Diseases

Zagreb, 10000, Croatia

Location

CHC Rijeka, Clinic of Internal Diseases

Zagreb, 1000, Croatia

Location

H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241

Copenhagen, 2100, Denmark

Location

Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique

Nice, 6202, France

Location

Groupe Hospitalier Sud Réunion, Site Saint-Pierre

Saint-Pierre, 97448, France

Location

Klinik Essen Süd, Evangelisches Krankenhaus

Essen, 45239, Germany

Location

Leitender Oberarzt/Klinik für Onkologie und Hämatologie

Frankfurt, 60488, Germany

Location

Universität Göttingen, Abteilung Hämatologie und Onkologie

Göttingen, 37075, Germany

Location

Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg

Halle, 06120, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Universitätsklinikum des Saarlandes

Homburg/Saar, 66424, Germany

Location

Universitätsklinikum Leipzig AöR

Leipzig, 04103, Germany

Location

Universitätsmedizin der johannes Gutenberg -Universität Mainz

Mainz, 55131, Germany

Location

University Hospital Marburg

Marburg, 35043, Germany

Location

Münchner Studienzentrum Klinikum Rechts der Isar

München, 81675, Germany

Location

Klinikum Nuernberg Nord

Nuremberg, 90419, Germany

Location

Universitätsklinikum Rostock

Rostock, 18057, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Szt István és Szt. Laszlo

Budapest, 1097, Hungary

Location

Belgyógyászati Klinika

Debrecen, 4032, Hungary

Location

Belgyógyászati Klinika Györ

Győr, 9042, Hungary

Location

Belgyógyászati Klinika es Kardiologial Központ

Szeged, 6720, Hungary

Location

The Soroka University Medical Center

Beersheba, 84101, Israel

Location

Rambam Medical Center Department of Hematology

Haifa, 31096, Israel

Location

Hadassah University Hospital Sharet Building Department of Hematology

Jerusalem, 91120, Israel

Location

Rabin Medical Center Belinson Campus

Petah Tikva, 49100, Israel

Location

Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica

Bologna, 40138, Italy

Location

Ospedale Policlinico Careggi

Florence, 50134, Italy

Location

VU Medical Center, Department of Haematology

Amsterdam, 7081 HV, Netherlands

Location

University Medical Center Groningen UMCG, Department of Haematologie

Groningen, 9700, Netherlands

Location

Erasmus University Medical Center

Rotterdam, 3015, Netherlands

Location

Isala Clinics, Department of Haematololgy

Zwolle, 8025 AB, Netherlands

Location

Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii

Gdansk, 80-952, Poland

Location

Małopolskie Centrum Medyczne

Krakow, 30-510, Poland

Location

Wojewódzki Szpital Specjalistyczny im M. Kopernika w Łodzi Oddział Hematologii - Klinika Hematologii

Lodz, 93-510, Poland

Location

Szpital Wojewódzki w Opolu/Oddział Hematologii

Opole, 45-051, Poland

Location

MTZ Clinical Research Sp z o.o.

Warsaw, 02-106, Poland

Location

Instytut Hematologii i Transfuzjologii Klinika Hematologii

Warsaw, 02-776, Poland

Location

Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala

Warsaw, 04-141, Poland

Location

State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, 454087, Russia

Location

Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences

Moscow, 115478, Russia

Location

Research Center of Haematology

Moscow, 125167, Russia

Location

Narodny Onkologicky Ustav (NOU)

Bratislava, 83310, Slovakia

Location

Klinika Hematologie a Onkohematologie FNLP a LF UPJS

Košice, 04066, Slovakia

Location

Tygerberg Hospital, Department of Radiation Oncology

Bellville, 7505, South Africa

Location

Drs pirjol, Szpak and Moodley Inc.

Durban, 4126, South Africa

Location

Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital

Pretoria, 0002, South Africa

Location

Pretoria Academic Hospital, Department of Radiation Oncology

Pretoria, 0002, South Africa

Location

Complexo Hospitalario a Coruna

A Coruña, 15006, Spain

Location

Hospital Clinico Universitario de Santiago

A Coruña, 15706, Spain

Location

ICO Hospital Germans Trias i Pujol

Badalona, 08918, Spain

Location

Hospital Duran i Reinals

Barcelona, 08007, Spain

Location

Hospital Universitario Virgen de la Arrixaca

El Palmar, 30120, Spain

Location

Hospital General Universitario Gregorio Maranón

Madrid, CP 28007, Spain

Location

Hospital Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33006, Spain

Location

St James's Institute of Oncology Bexley Wing

Leeds, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry

London, EC1A 7BE, United Kingdom

Location

The Christie NHS Foundation Trust, The Christie Hospital,

Manchester, M20 4BX, United Kingdom

Location

Northern Centre for Cancer Care, Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

The Royal Marsden Haemato-Oncology Wards

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26921086 RESULT

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

belinostat

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Gajanan Bhat, PhD
• Organization: Spectrum Pharmaceuticals

Gajanan.Bhat@sppirx.com

949-743-9219

Study Officials

• Peter Brown, MD

  H:S Rigshospitalet, Department of Hematology, Denmark

  PRINCIPAL INVESTIGATOR

• Pier L Zinzani, MD

  Università di Bologna, Italy

  PRINCIPAL INVESTIGATOR

• André Bosly, MD

  Cliniques Universitaires UCL Mont Godinne, Belgium

  PRINCIPAL INVESTIGATOR

• Georges Fillet, MD

  University of Liege, Belgium

  PRINCIPAL INVESTIGATOR

• Eric van den Neste, MD

  Clinique Universitaier Saint Luc, Belgium

  PRINCIPAL INVESTIGATOR

• Nicolas Monier, MD

  Hôpital de l'Archet 1 Centre Hospitalier Universitaire (CHU) de Nice, France

  PRINCIPAL INVESTIGATOR

• Elisabeth Perez, MD

  Groupe Hospitalier Sud Réunion, France

  PRINCIPAL INVESTIGATOR

• Maria Delioukina, MD

  City of Hope National Medical Center, USA

  PRINCIPAL INVESTIGATOR

• Adam Lerner, MD

  Boston Medical Center, USA

  PRINCIPAL INVESTIGATOR

• Lydia Dreosti, MD

  Pretoria Academic Hospital, South Africa

  PRINCIPAL INVESTIGATOR

• D. Moodley, MD

  Drs Pirjol, Szpak and Moodley Inc, Durban, South Africa

  PRINCIPAL INVESTIGATOR

• Hanneke C. Kluin-Nelemans, MD

  University Medical Center Groningen UMCG, The Netherlands

  PRINCIPAL INVESTIGATOR

• G. Sissolak, MD

  Tygerberg Hospital, Cape Town, South Africa

  PRINCIPAL INVESTIGATOR

• L. Verdonk, MD

  Isala Clinics, Zwolle, The Netherlands

  PRINCIPAL INVESTIGATOR

• O. Visser, MD

  VU Medical Center, Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

• Owen A. O'Connor, MD

  New York University Cancer Institute, USA

  PRINCIPAL INVESTIGATOR

• Sarit Assouline, MD

  McGill University, Department of Oncology Clinical Research Program, Montreal, Canada

  PRINCIPAL INVESTIGATOR

• Juan Manuel Sancho Cia, MD

  ICO Hospital Germans Trias i Pujol, Badalona, Spain

  PRINCIPAL INVESTIGATOR

• Consolación Rayon, MD

  Hospital Universitario Central de Asturias, Oviedo, Spain

  PRINCIPAL INVESTIGATOR

• Sonia Gonzales, MD

  Hospital Clinico Universitario de Santiago, Santiago de Compostella, Spain

  PRINCIPAL INVESTIGATOR

• Lorenz Trümper, MD

  Universität Göttingen, Abteilung Hämatologie und Onkologie, Göttingen, Germany

  PRINCIPAL INVESTIGATOR

• Andreas Viardot, MD

  Universitätsklinikum Ulm, Ulm, Germany

  PRINCIPAL INVESTIGATOR

• Georg Hess, MD

  Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany

  PRINCIPAL INVESTIGATOR

• Hans-Heinrich Wolf, MD

  Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg, Halle, Germany

  PRINCIPAL INVESTIGATOR

• Andreas Neubauer, MD

  University Hospital Marburg, Marburg, Germany

  PRINCIPAL INVESTIGATOR

• Michele Frank, MD

  Cascade Cancer Center

  PRINCIPAL INVESTIGATOR

• Madeleine Duvic, MD

  UT - M. D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Andrei Shustov, MD

  Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance

  PRINCIPAL INVESTIGATOR

• Melissa Runge-Morris, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

• Nalini Janakiraman, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

• Amanda Cashen, MD

  Wasington University School of Medicine- Division of Oncology

  PRINCIPAL INVESTIGATOR

• Beata Holkova, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

• Mohammad Tirgan, MD

  Hematology Associates

  PRINCIPAL INVESTIGATOR

• Bernard Poiesz, MD

  Upstate Medical Univeristy Syracuse

  PRINCIPAL INVESTIGATOR

• Charles Farber, MD

  Morristown Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Zale Bernstein, MD

  Erie County Medical Center (Roswell Park)

  PRINCIPAL INVESTIGATOR

• Ralph Boccia, MD

  Center for Cancers and Blood Disorders

  PRINCIPAL INVESTIGATOR

• David Grinblatt, MD

  Kellogg Cancer Care Center

  PRINCIPAL INVESTIGATOR

• Laura Blakely, MD

  Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)

  PRINCIPAL INVESTIGATOR

• David Dennis, MD

  Boca Raton Clinical Research Associates

  PRINCIPAL INVESTIGATOR

• Fernando Camacho, MD

  Bronx River Medical Associates, PC

  PRINCIPAL INVESTIGATOR

• Eliot Epner, MD

  Penn State Hershey Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: December 15, 2008
• Primary Completion: November 5, 2013
• Study Completion: October 27, 2014
• Last Updated: October 29, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (7); IT (2); NL (4); DE (13); IL (4); SL (2); CR (4); US (42); CA (3); RU (3); ZA (4); ES (8); GB (6); PL (8); DK (1); FR (2); HU (4)