Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

Peripheral T-cell Lymphoma Clinical Trial

— PTCL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00865969
• Other study ID #: PXD101-CLN-19
• Secondary ID: 2008-005843-40
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 2008
• Est. completion date: October 27, 2014

Study information

• Verified date: October 2021
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

This is an open-label, multicenter, single arm efficacy and safety study in participants with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy.

Approximately 120 participants will be enrolled. Participants will be treated with 1000 mg/m^2 belinostat administered as a 30-minute IV infusion on Days 1-5 of every 3-week cycle until there is disease progression or unmanageable treatment-related toxicities.

The primary study endpoint is objective response rate (ORR) based on the International Harmonization Project (IHP) revision International Working Group (IWG) criteria. Safety will be evaluated during the study and for 30 days after the last administration of study drug. Adverse events and laboratory studies will be graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 3.0.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 27, 2014
• Est. primary completion date: November 5, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

Drug:
• Belinostat

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerpen
Belgium	ZNA Stuivenberg	Antwerpen
Belgium	AZ St. Jan	Brügge
Belgium	Clinique Universitaire Saint Luc, Service Hématologie	Bruxelles
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	University of Liege, Divisions of Hematology and Medical Oncology	Liege
Belgium	Cliniques Universitaires UCL Mont Godinne, Service Hématologie	Yvoir
Canada	McGill University	Montreal
Canada	CHA Hôpital de l'Enfant-Jésus	Quebec City	Quebec
Canada	University of British Columbia	Vancouver	British Columbia
Croatia	CHC Split Clinic of Internal Diseases	Split
Croatia	CHC Rijeka, Clinic of Internal Diseases	Zagreb
Croatia	CHC Zagreb Clinic of Internal Diseases	Zagreb
Croatia	UH Dubrava Clinic of Internal Diseases	Zagreb
Denmark	H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241	Copenhagen
France	Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique	Nice
France	Groupe Hospitalier Sud Réunion, Site Saint-Pierre	Saint-Pierre Cedex
Germany	Klinik Essen Süd, Evangelisches Krankenhaus	Essen
Germany	Leitender Oberarzt/Klinik für Onkologie und Hämatologie	Frankfurt
Germany	Universität Göttingen, Abteilung Hämatologie und Onkologie	Göttingen
Germany	Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg	Halle
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Universitätsklinikum des Saarlandes	Homburg/Saar
Germany	Universitätsklinikum Leipzig AöR	Leipzig
Germany	Universitätsmedizin der johannes Gutenberg -Universität Mainz	Mainz
Germany	University Hospital Marburg	Marburg
Germany	Münchner Studienzentrum Klinikum Rechts der Isar	München
Germany	Klinikum Nuernberg Nord	Nuernberg
Germany	Universitätsklinikum Rostock	Rostock
Germany	Universitätsklinikum Ulm	Ulm
Hungary	Szt István és Szt. Laszlo	Budapest
Hungary	Belgyógyászati Klinika	Debrecen
Hungary	Belgyógyászati Klinika Györ	Györ
Hungary	Belgyógyászati Klinika es Kardiologial Központ	Szeged
Israel	The Soroka University Medical Center	Beer Sheva
Israel	Rambam Medical Center Department of Hematology	Haifa
Israel	Hadassah University Hospital Sharet Building Department of Hematology	Jerusalem
Israel	Rabin Medical Center Belinson Campus	Petach Tikva
Italy	Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica	Bologna
Italy	Ospedale Policlinico Careggi	Firenze
Netherlands	VU Medical Center, Department of Haematology	Amsterdam
Netherlands	University Medical Center Groningen UMCG, Department of Haematologie	Groningen
Netherlands	Erasmus University Medical Center	Rotterdam
Netherlands	Isala Clinics, Department of Haematololgy	Zwolle
Poland	Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii	Gdansk
Poland	Malopolskie Centrum Medyczne	Kraków
Poland	Wojewódzki Szpital Specjalistyczny im M. Kopernika w Lodzi Oddzial Hematologii - Klinika Hematologii	Lódz
Poland	Szpital Wojewódzki w Opolu/Oddzial Hematologii	Opole
Poland	Instytut Hematologii i Transfuzjologii Klinika Hematologii	Warszawa
Poland	Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie	Warszawa	Mazowieckie
Poland	MTZ Clinical Research Sp z o.o.	Warszawa
Poland	Wojskowy Instytut Medyczny Klinika Chorób/Wewnetrznych i Hematologii Centralnego Szpitala	Warszawa
Russian Federation	State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary	Chelyabinsk
Russian Federation	Research Center of Haematology	Moscow
Russian Federation	Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences	Moscow
Slovakia	Narodny Onkologicky Ustav (NOU)	Bratislava
Slovakia	Klinika Hematologie a Onkohematologie FNLP a LF UPJS	Kosice
South Africa	Tygerberg Hospital, Department of Radiation Oncology	Bellville
South Africa	Drs pirjol, Szpak and Moodley Inc.	Durban
South Africa	Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital	Pretoria
South Africa	Pretoria Academic Hospital, Department of Radiation Oncology	Pretoria
Spain	Complexo Hospitalario a Coruna	A Coruna
Spain	Hospital Clinico Universitario de Santiago	A Coruña
Spain	ICO Hospital Germans Trias i Pujol	Badalona
Spain	Hospital Duran i Reinals	Barcelona
Spain	Hospital Universitario Virgen de la Arrixaca	El Palmar
Spain	Hospital General Universitario Gregorio Maranón	Madrid
Spain	Hospital Universitario Morales Meseguer	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo
United Kingdom	St James's Institute of Oncology Bexley Wing	Leeds
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry	London
United Kingdom	The Christie NHS Foundation Trust, The Christie Hospital,	Manchester
United Kingdom	Northern Centre for Cancer Care, Freeman Hospital	Newcastle Upon Tyne
United Kingdom	The Royal Marsden Haemato-Oncology Wards	Sutton
United States	Georgia Health Sciences University	Augusta	Georgia
United States	Hematology Associates	Bedford	Ohio
United States	Center for Cancers and Blood Disorders	Bethesda	Maryland
United States	St Luke's Cancer Center	Bethlehem	Pennsylvania
United States	Boca Raton Clinical Research Associates	Boca Raton	Florida
United States	Boston University Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Bronx River Medical Associates, PC	Bronx	New York
United States	Erie County Medical Center (Roswell Park)	Buffalo	New York
United States	Associates In Oncology and Hematology	Chattanooga	Tennessee
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Henry Ford Health System	Detroit	Michigan
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Kellogg Cancer Care Center	Evanston	Illinois
United States	Northern New Jersey Cancer Associates	Hackensack	New Jersey
United States	Penn State Hershey Cancer Institute	Hershey	Pennsylvania
United States	UT - M. D. Anderson Cancer Center	Houston	Texas
United States	Cascade Cancer Center	Kirkland	Washington
United States	University of Tennessee Cancer Institute	Knoxville	Tennessee
United States	Wilshire Oncology Medical Group, Inc	La Verne	California
United States	Monter Cancer Center	Lake Success	New York
United States	Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)	Memphis	Tennessee
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Yale Cancer Center-Section of Medical Oncology	New Haven	Connecticut
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	New York University	New York	New York
United States	New York University Cancer Institute	New York	New York
United States	Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland	Niles	Illinois
United States	Comprehensive Cancer Center	Palm Springs	California
United States	Illinois CancerCare, P.C.	Peoria	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Massey Cancer Center	Richmond	Virginia
United States	Saint Louis University	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	The UT Health Science Centre at San Antonio	San Antonio	Texas
United States	Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance	Seattle	Washington
United States	Avera Cancer Center	Sioux Falls	South Dakota
United States	Upstate Medical Univeristy Syracuse	Syracuse	New York
United States	Oncology Associates of Bridgeport	Trumbull	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc	Onxeo

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Croatia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Poland,  Russian Federation,  Slovakia,  South Africa,  Spain,  United Kingdom, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Population Pharmacokinetics		24 months
Primary	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	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	Overall Survival	Overall Survival was the time from first administration of study treatment until the date of death.	24 months
Secondary	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.	24 months