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Peripheral T-cell LymphomaPhase 2PTCLNCT00865969

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

A Phase 2 study testing Belinostat in people with Peripheral T-cell Lymphoma, run by Spectrum Pharmaceuticals, Inc at 117 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral T-cell Lymphoma
What is being tested?
Belinostat
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
117 sitesin 17 countries
Study dates
15 Dec 2008to 27 Oct 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 9Show fewer
  • 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.

Trial locations and contacts

117 sites in 17 countries.

117 sites in 17 countries

United States42 sites

  • Georgia Health Sciences University

    Augusta, Georgia, 30912-3125

  • Hematology Associates

    Bedford, Ohio, 44146

  • Center for Cancers and Blood Disorders

    Bethesda, Maryland, 20817

  • St Luke's Cancer Center

    Bethlehem, Pennsylvania, 18015

  • Boca Raton Clinical Research Associates

    Boca Raton, Florida, 33432

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Erie County Medical Center (Roswell Park)

    Buffalo, New York, 14215

  • Associates In Oncology and Hematology

    Chattanooga, Tennessee, 37421

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Kellogg Cancer Care Center

    Evanston, Illinois, 60201

  • Northern New Jersey Cancer Associates

    Hackensack, New Jersey, 07601

  • Penn State Hershey Cancer Institute

    Hershey, Pennsylvania, 17033

  • UT - M. D. Anderson Cancer Center

    Houston, Texas, 77030

  • Cascade Cancer Center

    Kirkland, Washington, 98304

  • University of Tennessee Cancer Institute

    Knoxville, Tennessee, 37920

  • Wilshire Oncology Medical Group, Inc

    La Verne, California, 91750

  • Monter Cancer Center

    Lake Success, New York, 11067

  • Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)

    Memphis, Tennessee, 38138

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Yale Cancer Center-Section of Medical Oncology

    New Haven, Connecticut, 06520

  • New York University Cancer Institute

    New York, New York, 10016

  • New York University

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Illinois CancerCare, P.C.

    Peoria, Illinois, 61615

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Massey Cancer Center

    Richmond, Virginia, 23298-0035

  • The UT Health Science Centre at San Antonio

    San Antonio, Texas, 78229

  • Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Avera Cancer Center

    Sioux Falls, South Dakota, 57105

  • Saint Louis University

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Upstate Medical Univeristy Syracuse

    Syracuse, New York, 13210

  • Bronx River Medical Associates, PC

    The Bronx, New York, 10467

  • Oncology Associates of Bridgeport

    Trumbull, Connecticut, 06611

Other trials in United States

Germany13 sites

  • Klinik Essen Süd, Evangelisches Krankenhaus

    Essen, 45239

  • Leitender Oberarzt/Klinik für Onkologie und Hämatologie

    Frankfurt, 60488

  • Universität Göttingen, Abteilung Hämatologie und Onkologie

    Göttingen, 37075

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

    Halle, 06120

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66424

  • Universitätsklinikum Leipzig AöR

    Leipzig, 04103

  • Universitätsmedizin der johannes Gutenberg -Universität Mainz

    Mainz, 55131

  • University Hospital Marburg

    Marburg, 35043

  • Münchner Studienzentrum Klinikum Rechts der Isar

    München, 81675

  • Klinikum Nuernberg Nord

    Nuremberg, 90419

  • Universitätsklinikum Rostock

    Rostock, 18057

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Poland8 sites

  • Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii

    Gdansk, 80-952

  • Małopolskie Centrum Medyczne

    Krakow, 30-510

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

    Lodz, 93-510

  • Szpital Wojewódzki w Opolu/Oddział Hematologii

    Opole, 45-051

  • Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie

    Warsaw, Masovian Voivodeship, 02-781

  • MTZ Clinical Research Sp z o.o.

    Warsaw, 02-106

  • Instytut Hematologii i Transfuzjologii Klinika Hematologii

    Warsaw, 02-776

  • Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala

    Warsaw, 04-141

Other trials in Poland

Spain8 sites

  • Complexo Hospitalario a Coruna

    A Coruña, 15006

  • Hospital Clinico Universitario de Santiago

    A Coruña, 15706

  • ICO Hospital Germans Trias i Pujol

    Badalona, 08918

  • Hospital Duran i Reinals

    Barcelona, 08007

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital General Universitario Gregorio Maranón

    Madrid, CP 28007

  • Hospital Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Universitario Central de Asturias

    Oviedo, 33006

Other trials in Spain

Belgium7 sites

  • ZNA Middelheim

    Antwerp, 2020

  • ZNA Stuivenberg

    Antwerp, 2060

  • AZ St. Jan

    Bruges, 8000

  • Clinique Universitaire Saint Luc, Service Hématologie

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • University of Liege, Divisions of Hematology and Medical Oncology

    Liège, 4000

  • Cliniques Universitaires UCL Mont Godinne, Service Hématologie

    Yvoir, 5530

Other trials in Belgium

United Kingdom6 sites

  • St James's Institute of Oncology Bexley Wing

    Leeds, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

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

    London, EC1A 7BE

  • The Christie NHS Foundation Trust, The Christie Hospital,

    Manchester, M20 4BX

  • Northern Centre for Cancer Care, Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • The Royal Marsden Haemato-Oncology Wards

    Sutton, SM2 5PT

Other trials in United Kingdom

Croatia4 sites

  • CHC Split Clinic of Internal Diseases

    Split, 21000

  • CHC Zagreb Clinic of Internal Diseases

    Zagreb, 10000

  • UH Dubrava Clinic of Internal Diseases

    Zagreb, 10000

  • CHC Rijeka, Clinic of Internal Diseases

    Zagreb, 1000

Other trials in Croatia

Hungary4 sites

  • Szt István és Szt. Laszlo

    Budapest, 1097

  • Belgyógyászati Klinika

    Debrecen, 4032

  • Belgyógyászati Klinika Györ

    Győr, 9042

  • Belgyógyászati Klinika es Kardiologial Központ

    Szeged, 6720

Other trials in Hungary

Israel4 sites

  • The Soroka University Medical Center

    Beersheba, 84101

  • Rambam Medical Center Department of Hematology

    Haifa, 31096

  • Hadassah University Hospital Sharet Building Department of Hematology

    Jerusalem, 91120

  • Rabin Medical Center Belinson Campus

    Petah Tikva, 49100

Other trials in Israel

Netherlands4 sites

  • VU Medical Center, Department of Haematology

    Amsterdam, 7081 HV

  • University Medical Center Groningen UMCG, Department of Haematologie

    Groningen, 9700

  • Erasmus University Medical Center

    Rotterdam, 3015

  • Isala Clinics, Department of Haematololgy

    Zwolle, 8025 AB

Other trials in Netherlands

South Africa4 sites

  • Tygerberg Hospital, Department of Radiation Oncology

    Bellville, 7505

  • Drs pirjol, Szpak and Moodley Inc.

    Durban, 4126

  • Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital

    Pretoria, 0002

  • Pretoria Academic Hospital, Department of Radiation Oncology

    Pretoria, 0002

Other trials in South Africa

Canada3 sites

  • McGill University

    Montreal, H2W1S6

  • CHA Hôpital de l'Enfant-Jésus

    Québec, Quebec, G1J1Z4

  • University of British Columbia

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Russia3 sites

  • State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk, 454087

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

    Moscow, 115478

  • Research Center of Haematology

    Moscow, 125167

Other trials in Russia

France2 sites

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

    Nice, 6202

  • Groupe Hospitalier Sud Réunion, Site Saint-Pierre

    Saint-Pierre, 97448

Other trials in France

Italy2 sites

  • Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica

    Bologna, 40138

  • Ospedale Policlinico Careggi

    Florence, 50134

Other trials in Italy

Slovakia2 sites

  • Narodny Onkologicky Ustav (NOU)

    Bratislava, 83310

  • Klinika Hematologie a Onkohematologie FNLP a LF UPJS

    Košice, 04066

Other trials in Slovakia

Denmark1 site

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

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

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.

Read the 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.

Being tested
Belinostat
Keywords
Belinostat, Peripheral T-cell lymphoma, PXD101, PTCL, HDAC inhibitor, Histone deacetylase inhibitor
Medical subject headings
Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelinostatDrug

    Also called PXD101

Study groups in NCT00865969
Study groupRoleWhat they receive
BelinostatExperimentalBelinostat 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.
Receives: Drug: Belinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (6)

  1. 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.

    Measured: 24 months

  2. 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.

    Measured: 24 months

  3. 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.

    Measured: 24 months

  4. 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.

    Measured: 24 months

  5. Overall Survival

    Overall Survival was the time from first administration of study treatment until the date of death.

    Measured: 24 months

  6. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2009 (estimated)
  2. Study start15 Dec 2008
  3. Primary completion5 Nov 2013
  4. Study completion27 Oct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00865969
Sponsor's protocol ID
PXD101-CLN-19
Other IDs
2008-005843-40, 2008
Acronym
PTCL
Status last verified
Oct 2021
First submitted
19 Mar 2009
Last updated
29 Oct 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26921086

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belinostat in people with Peripheral T-cell Lymphoma, run by Spectrum Pharmaceuticals, Inc at 117 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Germany, Poland, Spain, Belgium and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00865969, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.

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