A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma
A Phase II, Multicenter, Open-Label Trial Evaluating The Activity And Tolerability Of Romidepsin (Depsipeptide, FK228) In Progressive Or Relapsed Peripheral T-Cell Lymphoma Following Prior Systemic Therapy (GPI-06-0002)
2 other identifiers
interventional
131
10 countries
90
Brief Summary
The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2007
Longer than P75 for phase_2
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2007
CompletedFirst Posted
Study publicly available on registry
January 25, 2007
CompletedStudy Start
First participant enrolled
June 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2010
CompletedResults Posted
Study results publicly available
August 13, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2018
CompletedFebruary 11, 2020
January 1, 2020
3.4 years
January 23, 2007
July 5, 2012
January 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee
Complete Response (CR): \>75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed \>75% in the sum of the product diameters (SPD) from baseline. Individual nodes previously confluent must have regressed by \>75% in their SPD.
Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
Secondary Outcomes (6)
Percentage of Participants With Objective Disease Response
Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
Duration of Objective Disease Response
Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
Duration of Complete Disease Response
Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
Time to Disease Progression
Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status
From Baseline up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
- +1 more secondary outcomes
Study Arms (1)
Romidepsin
EXPERIMENTALParticipants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Interventions
Romidepsin intravenously (through a vein) over 4 hours on Days 1, 8 and 15 of each 28-day cycle.
Eligibility Criteria
You may qualify if:
- Patients must fulfill all of the following criteria to be eligible for study participation and have:
- Histologically confirmed PTCL not otherwise specified, angioimmunoblastic T-cell lymphoma, extranodal natural killer (NK)/T-cell lymphoma nasal type, enteropathy- type T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous γδ T-cell lymphoma (excludes mycosis fungoides or Sezary syndrome), transformed mycosis fungoides, hepatosplenic T-cell lymphoma, anaplastic large cell lymphoma (ALCL; anaplastic lymphoma kinase \[ALK\]-1 negative), or patients with ALK 1 expressing ALCL (ALK-1 positive) who have relapsed disease after autologous stem cell transplant (ASCT);
- Age ≥18 years;
- Written informed consent;
- Progressive disease following at least one systemic therapy or refractory to at least one prior systemic therapy;
- Measurable disease according to the International Workshop Response (IWC) criteria and/or measurable cutaneous disease;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Negative urine or serum pregnancy test on females of childbearing potential; and
- All women of childbearing potential must use an effective barrier method of contraception (either an intrauterine contraceptive device \[IUCD\] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male patients should use a barrier method of contraception during the treatment period and for at least 1 month thereafter. Hormonal methods of contraception such as the contraceptive pill or patch (particularly those containing ethinyl-estradiol) should be avoided due to a potential drug interaction.
You may not qualify if:
- Patients are ineligible for entry if any of the following criteria are met:
- Known central nervous system (CNS) lymphoma \[computed tomography (CT) or magnetic resonance imaging (MRI) scans are required only if brain metastasis is suspected clinically\];
- Chemotherapy or immunotherapy within 4 weeks of study entry (6 weeks if nitrosoureas given);
- Initiation of corticosteroids during study (defined as 7 days prior to Cycle 1 Day 1\[C1D1\] until study drug discontinuation)
- Patients treated with a pulse of steroids were to discontinue steroid use 7 days prior to C1D1 and have a repeat CT scan and disease assessment after discontinuation of corticosteroids and before starting romidepsin;
- Concomitant use of any other anti-cancer therapy;
- Concomitant use of any investigational agent;
- Use of any investigational agent within 4 weeks of study entry;
- Any known cardiac abnormalities such as:
- Congenital long QT syndrome;
- QTc interval \>480 milliseconds (msec);
- A myocardial infarction within 6 months of C1D1. Patients with a history of myocardial infraction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate;
- Other significant electrocardiogram (ECG) abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).
- Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV. In any patient in whom there is doubt, the patient should be referred to a cardiologist for evaluation;
- An ECG recorded at screening showing significant ST depression (ST depression of ≥2 mm, measured from isoelectric line to the ST segment at a point 60 msec at the end of the QRS complex). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (90)
Moore UCSD Cancer Center
La Jolla, California, 92093, United States
UCLA Division of Hematology Oncology
Los Angeles, California, 90095, United States
University of California, San Francisco
San Francisco, California, 94143-0324, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
Yale University
New Haven, Connecticut, 06519, United States
Georgetown University IRB
Washington D.C., District of Columbia, 20007, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Cancer Centers of Florida, PA
Orlando, Florida, 32806-1124, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9416, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Augusta Oncology Associates, P.C.
Augusta, Georgia, 30901, United States
Central Georgia Cancer Care
Macon, Georgia, 31201, United States
Cancer Care and Hematology Specialists of Chicagoland
Arlington Heights, Illinois, 60005, United States
Hematology Oncology Assoc. of IL Orchard Research LLC
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
St. Agnes - Medical Center
Baltimore, Maryland, 21229-5299, United States
Center for Cancer And Blood Disorders
Bethesda, Maryland, 20817, United States
Center for Cancer Research CAMC
Bethesda, Maryland, 20892, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Minnesota Oncology Hematology, PA
Burnsville, Minnesota, 55337, United States
St. Joseph Oncology, Inc
Saint Joseph, Missouri, 64507, United States
Arch Medical Services
St Louis, Missouri, 63141, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68114, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
Taussig Cancer Center Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227, United States
Accelerated Community Oncology Research Network Inc ACORN
Memphis, Tennessee, 38138, United States
Mamie McFadden Ward Center
Beaumont, Texas, 77702-1449, United States
Methodist Charlton Cancer Center
Dallas, Texas, 75237, United States
UT Southwestern Medical Center Simmons Comprehensive Cancer Center
Dallas, Texas, 75390-8565, United States
El Paso Cancer Treatment Center
El Paso, Texas, 79915, United States
Texas Oncology, P.A.-Fort Worth
Fort Worth, Texas, 76104, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Allison Cancer Center
Midland, Texas, 79701, United States
US Oncology
Plano, Texas, 75093, United States
HOAST
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Texas Oncology, PA
Waco, Texas, 76712, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
Mater Private Medical Centre - Haematology and Oncology Clinics of Australasia Research Centre
South Brisbane, Queensland, 4101, Australia
Peter MacCallum Cancer Centre
East Melbourne, 3002, Australia
St. Vincent Hospital
Fitzroy, 3065, Australia
Royal North Shore Hospital
St Leonards, 2065, Australia
University Hospital Brno
Brno, 625 00, Czechia
University Hospital Hradec Kralove
Hradec Králové, 500 05, Czechia
University Hospital of Kralovske Vinohrady
Prague, 100 34, Czechia
Charles University General Hospital
Prague, 128 08, Czechia
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33000, France
Hopital Henri Mondor
Créteil, 94010, France
Hopital Claude Huriez
Lille, 59037, France
CHU Nantes Hotel Dieu
Nantes, 44093, France
Hopital Saint-Louis
Paris, 75010, France
Service des Maladies du Sang
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Eugene Marquis
Rennes, 35033, France
Centre Henri Becquerel
Rouen, 79038, France
Charite Universitatsmedizin Berlin campus Virchow Klinikum Centrum fur Tumormedizin
Berlin, 13353, Germany
Uniklinik Koln
Cologne, 50937, Germany
Krankenhaus Nordwest
Frankfurt a.M., 60488, Germany
Georg-August-Universität Göttingen
Göttingen, 37075, Germany
Klinikum der Universitat Munchen-Grosshadern
München, D-81377, Germany
Klinikum Nurnberg Nord
Nuremberg, D- 90419, Germany
UKT Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Klinika Hematologii Akademickie Centrum Kliniczne Akademii Medycznej w Gdansku
Gdansk, 80-952, Poland
Oddzial Kliniczny Kliniki Hematologii
Krakow, 31 501, Poland
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
Lodz, 93-510, Poland
Klinika Nowotworow Ukladu Chlonnego
Warsaw, 02 781, Poland
Hospital Universitario Vall D Hebron
Barcelona, 08035, Spain
Hospital de La Princesa
Madrid, 28006, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Clinica Universitaria de Navarra
Pamplona, 31008, Spain
Hospital Universitario de Salamanca
Salamanca, 37003, Spain
Hospital Marques de Valdecilla
Santandar, 39008, Spain
Lund University Hosptial
Lund, 22185, Sweden
Akademiska Sjukhuset
Uppsala, 75185, Sweden
Dnipropetrovsk State Medical Academy
Dnipropetrovsk, 49102, Ukraine
National Cancer Institute Department Of Conservative Methods Of Treatment
Kyiv, 03022, Ukraine
R.E.Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology
Kyiv, 03115, Ukraine
Institute of Blood Pathology and Transfusion Medicine of the AMS of Ukraine
Lviv, 79044, Ukraine
Barts Cancer Institute, Queen Mary University of London, Charterhouse Square
London, EC1A 7BE, United Kingdom
Guy's and St. Thomas' Hospital
London, SE1 9RT, United Kingdom
Catherine Lewis Centre - Hematology Department
London, W12 0HS, United Kingdom
Royal Free Hospital
London Hampstead, NW3 2QG, United Kingdom
Somers Cancer Research Building
Southampton, SO16 6YD, United Kingdom
Related Publications (7)
Foss F, Pro B, Miles Prince H, Sokol L, Caballero D, Horwitz S, Coiffier B. Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T-cell lymphoma. Cancer Med. 2017 Jan;6(1):36-44. doi: 10.1002/cam4.939. Epub 2016 Dec 16.
PMID: 27981793BACKGROUNDShustov A, Coiffier B, Horwitz S, Sokol L, Pro B, Wolfson J, Balser B, Eisch R, Popplewell L, Prince HM, Allen SL, Piekarz R, Bates S. Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials. Leuk Lymphoma. 2017 Oct;58(10):2335-2341. doi: 10.1080/10428194.2017.1295143. Epub 2017 Mar 7.
PMID: 28264616BACKGROUNDCoiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012 Feb 20;30(6):631-6. doi: 10.1200/JCO.2011.37.4223. Epub 2012 Jan 23.
PMID: 22271479RESULTHorwitz S, Coiffier B, Foss F, Prince HM, Sokol L, Greenwood M, Caballero D, Morschhauser F, Pinter-Brown L, Iyer SP, Shustov A, Nichols J, Balser J, Balser B, Pro B. Utility of (1)(8)fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Apr;26(4):774-779. doi: 10.1093/annonc/mdv010. Epub 2015 Jan 20.
PMID: 25605745RESULTFoss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. J Hematol Oncol. 2016 Mar 10;9:22. doi: 10.1186/s13045-016-0243-8.
PMID: 26965915DERIVEDFoss F, Coiffier B, Horwitz S, Pro B, Prince HM, Sokol L, Greenwood M, Lerner A, Caballero D, Baran E, Kim E, Nichols J, Balser B, Wolfson J, Whittaker S. Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma. Biomark Res. 2014 Sep 8;2:16. doi: 10.1186/2050-7771-2-16. eCollection 2014.
PMID: 25279222DERIVEDCoiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014 Jan 23;7:11. doi: 10.1186/1756-8722-7-11.
PMID: 24456586DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director, Clinical Trials Disclosure
- Organization
- Celgene Corporation
Study Officials
- STUDY DIRECTOR
Myron Czuczman, MD
Celgene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
January 23, 2007
First Posted
January 25, 2007
Study Start
June 19, 2007
Primary Completion
November 11, 2010
Study Completion
May 17, 2018
Last Updated
February 11, 2020
Results First Posted
August 13, 2012
Record last verified: 2020-01