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Peripheral T-cell LymphomaPhase 2NCT00426764

A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma

A Phase 2 study testing Romidepsin in people with Peripheral T-cell Lymphoma, run by Celgene at 90 sites in 10 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 evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with 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?
Romidepsin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
90 sitesin 10 countries
Study dates
19 Jun 2007to 17 May 2018
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

  • 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;
Show all 10Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • Serum potassium ≥3.8 mmol/L and magnesium ≥0.85 mmol/L (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria);
  • 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.

Who cannot join

  • 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;
Show all 41Show fewer
  • 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;
  • Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or MRI;
  • A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);
  • Hypertrophic cardiomyopathy or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above);
  • Uncontrolled hypertension, i.e., blood pressure (BP) of ≥160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria;
  • Any cardiac arrhythmia requiring anti-arrhythmic medication;
  • Serum potassium <3.8 mmol/L or serum magnesium <0.85 mmol/L (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria);
  • Concomitant use of drugs that may cause a significant prolongation of the QTc;
  • Concomitant use of CYP3A4 significant or moderate inhibitors;
  • Concomitant use of therapeutic warfarin or another anticoagulant due to a potential drug interaction. Use of a small dose of a anticoagulant to maintain patency of venous access port and cannulas is permitted;
  • Clinically significant active infection;
  • Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
  • Previous extensive radiotherapy involving ≥30% of bone marrow (e.g., whole pelvis, half spine), excluding patients who have had total body irradiation as part of a conditioning regimen for ASCT;
  • Major surgery within 2 weeks of study entry;
  • Previous allogeneic stem cell transplant;
  • Inadequate bone marrow or other organ function as evidenced by:
  • Hemoglobin <9 g/dL (transfusions and/or erythropoietin are permitted);
  • Absolute neutrophil count (ANC) ≤1.0 × 10^9 cells/L [patients with neutropenia (ANC 1-1.5 10^9 cells/L) as a function of their disease may be supported with granulocyte-colony stimulating factor (G-CSF)];
  • Platelet count <100 × 10^9 cells/L or platelet count <75 × 10^9 cells/L if bone marrow disease involvement is documented;
  • Total bilirubin >2.0 × upper limit of normal (ULN) or >3.0 × ULN in the presence of demonstrable liver metastases;
  • Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 × ULN or >3.0 × ULN in the presence of demonstrable liver metastases; or
  • Serum creatinine >2.0 × ULN;
  • Patients who are pregnant or breast-feeding;
  • Coexistent second malignancy or history of prior solid organ malignancy within previous 3 years (excluding basal or squamous cell carcinoma of the skin, and in situ carcinoma of the cervix (CIN 1) that has been treated curatively);
  • Any prior history of a hematologic malignancy (other than T-cell lymphoma);
  • Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures; or
  • Prior exposure to romidepsin (other histone deacetylase inhibitors are allowed).

Trial locations and contacts

90 sites in 10 countries.

90 sites in 10 countries

United States45 sites

  • Cancer Care and Hematology Specialists of Chicagoland

    Arlington Heights, Illinois, 60005

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Augusta Oncology Associates, P.C.

    Augusta, Georgia, 30901

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • St. Agnes - Medical Center

    Baltimore, Maryland, 21229-5299

  • Mamie McFadden Ward Center

    Beaumont, Texas, 77702-1449

  • Center for Cancer And Blood Disorders

    Bethesda, Maryland, 20817

  • Center for Cancer Research CAMC

    Bethesda, Maryland, 20892

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Minnesota Oncology Hematology, PA

    Burnsville, Minnesota, 55337

  • Hematology Oncology Assoc. of IL Orchard Research LLC

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Taussig Cancer Center Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Methodist Charlton Cancer Center

    Dallas, Texas, 75237

  • UT Southwestern Medical Center Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390-8565

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • El Paso Cancer Treatment Center

    El Paso, Texas, 79915

  • Texas Oncology, P.A.-Fort Worth

    Fort Worth, Texas, 76104

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Moore UCSD Cancer Center

    La Jolla, California, 92093

  • UCLA Division of Hematology Oncology

    Los Angeles, California, 90095

  • Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • Central Georgia Cancer Care

    Macon, Georgia, 31201

  • Accelerated Community Oncology Research Network Inc ACORN

    Memphis, Tennessee, 38138

  • Allison Cancer Center

    Midland, Texas, 79701

  • Yale University

    New Haven, Connecticut, 06519

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Weill Cornell Medical College

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68114

  • Cancer Centers of Florida, PA

    Orlando, Florida, 32806-1124

  • US Oncology

    Plano, Texas, 75093

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97227

  • St. Joseph Oncology, Inc

    Saint Joseph, Missouri, 64507

  • HOAST

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • University of California, San Francisco

    San Francisco, California, 94143-0324

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Arch Medical Services

    St Louis, Missouri, 63141

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9416

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Texas Oncology, PA

    Waco, Texas, 76712

  • Georgetown University IRB

    Washington D.C., District of Columbia, 20007

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

France9 sites

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33000

  • Hopital Henri Mondor

    Créteil, 94010

  • Hopital Claude Huriez

    Lille, 59037

  • CHU Nantes Hotel Dieu

    Nantes, 44093

  • Hopital Saint-Louis

    Paris, 75010

  • Service des Maladies du Sang

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Eugene Marquis

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 79038

Other trials in France

Germany7 sites

  • Charite Universitatsmedizin Berlin campus Virchow Klinikum Centrum fur Tumormedizin

    Berlin, 13353

  • Uniklinik Koln

    Cologne, 50937

  • Krankenhaus Nordwest

    Frankfurt a.M., 60488

  • Georg-August-Universität Göttingen

    Göttingen, 37075

  • Klinikum der Universitat Munchen-Grosshadern

    München, D-81377

  • Klinikum Nurnberg Nord

    Nuremberg, D- 90419

  • UKT Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

Spain6 sites

  • Hospital Universitario Vall D Hebron

    Barcelona, 08035

  • Hospital de La Princesa

    Madrid, 28006

  • Hospital Universitario La Paz

    Madrid, 28046

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Hospital Universitario de Salamanca

    Salamanca, 37003

  • Hospital Marques de Valdecilla

    Santandar, 39008

Other trials in Spain

United Kingdom5 sites

  • Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

    London, EC1A 7BE

  • Guy's and St. Thomas' Hospital

    London, SE1 9RT

  • Catherine Lewis Centre - Hematology Department

    London, W12 0HS

  • Royal Free Hospital

    London Hampstead, NW3 2QG

  • Somers Cancer Research Building

    Southampton, SO16 6YD

Other trials in United Kingdom

Australia4 sites

  • Peter MacCallum Cancer Centre

    East Melbourne, 3002

  • St. Vincent Hospital

    Fitzroy, 3065

  • Mater Private Medical Centre - Haematology and Oncology Clinics of Australasia Research Centre

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital

    St Leonards, 2065

Other trials in Australia

Czechia4 sites

  • University Hospital Brno

    Brno, 625 00

  • University Hospital Hradec Kralove

    Hradec Králové, 500 05

  • University Hospital of Kralovske Vinohrady

    Prague, 100 34

  • Charles University General Hospital

    Prague, 128 08

Other trials in Czechia

Poland4 sites

  • Klinika Hematologii Akademickie Centrum Kliniczne Akademii Medycznej w Gdansku

    Gdansk, 80-952

  • Oddzial Kliniczny Kliniki Hematologii

    Krakow, 31 501

  • Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

    Lodz, 93-510

  • Klinika Nowotworow Ukladu Chlonnego

    Warsaw, 02 781

Other trials in Poland

Ukraine4 sites

  • Dnipropetrovsk State Medical Academy

    Dnipropetrovsk, 49102

  • National Cancer Institute Department Of Conservative Methods Of Treatment

    Kyiv, 03022

  • R.E.Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology

    Kyiv, 03115

  • Institute of Blood Pathology and Transfusion Medicine of the AMS of Ukraine

    Lviv, 79044

Other trials in Ukraine

Sweden2 sites

  • Lund University Hosptial

    Lund, 22185

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: 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)

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.

Read the detailed description

This is a Phase II, non-randomized, open-label, single-arm trial. This study is designed on the basis of complete response (CR) or unconfirmed CR [CR(u)] as the measure of efficacy, based on the best overall response of each patient. The sample size of 65 patients evaluable for efficacy would yield lower 95% confidence limits on the rate of CR + CR(u) that would range from 2.2% to 7.7%, if the observed rate of CR + CR(u) ranges from 8% to 15%. The study was amended to include an Extension Phase, during which patients at non-US sites who are benefitting from treatment can continue to receive romidepsin. The Extension Study Phase is active in EU countries where currently no Marketing Authorisation exists for romidepsin. Patients may remain on study until progressive disease occurs or they withdraw their consent and only serious adverse events and study drug administration data will continue to be collected and reported for these patients.

Being tested
Romidepsin
Keywords
peripheral T-cell lymphoma, T-cell lymphoma, romidepsin
Medical subject headings
Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell

What participants receive

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

  • RomidepsinDrug

    Also called ISTODAX, Depsipeptide, FK228

    Romidepsin intravenously (through a vein) over 4 hours on Days 1, 8 and 15 of each 28-day cycle.

Study groups in NCT00426764
Study groupRoleWhat they receive
RomidepsinExperimentalParticipants 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.
Receives: Drug: Romidepsin

What is being measured

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

  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.

    Measured: 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)

  1. Percentage of Participants With Objective Disease Response

    Objective disease response was defined as patients with a Complete Response, Unconfirmed Complete Response or a Partial Response (PR) according to the IWC 1999 assessed by an independent review committee: CR, Cru defined above, PR defined as ≥50% decrease in size of 6 largest dominant nodes and/or nodal masses \& extranodal index lesions and no increase of non-index lesions, liver, or spleen; no new sites of disease evident; skin lesions decreased by ≥50%.

    Measured: 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.

  2. Duration of Objective Disease Response

    Duration of response was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.

    Measured: 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.

  3. Duration of Complete Disease Response

    Duration of response was defined as the number of days from the date of the first disease response (Complete or Unconfirmed Complete) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.

    Measured: 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.

  4. Time to Disease Progression

    Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression as reported by the independent review committee and was determined using Kaplan-Meier product-limit estimates.

    Measured: 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.

  5. Change in Eastern Cooperative Oncology Group (ECOG) Performance Status

    The ECOG scale is as follows: Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair. Data reported is the shift from Baseline ECOG score to best on-study assessment score.

    Measured: From Baseline up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.

  6. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    An adverse event or experience (AE) is defined as any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event or condition. Related AEs are defined as those considered by the Investigator to have a possible, probable, or very likely/certain relationship to the study drug. AEs were graded as mild (1), moderate (2), severe (3), lifethreatening (4), or death (5). TEAEs occurred from the first dose of study medication through the end of the study (30 days post last dose) or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through end of study.

    Measured: From first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. Mean duration of treatment up until 30 September 2012 (data cutoff for analysis) was 169 days.

Timeline

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

  1. First posted25 Jan 2007 (estimated)
  2. Study start19 Jun 2007
  3. Primary completion11 Nov 2010
  4. Study completion17 May 2018

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
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00426764
Sponsor's protocol ID
GPI-06-0002
Other IDs
2006-006228-21
Status last verified
Jan 2020
First submitted
23 Jan 2007
Last updated
11 Feb 2020
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27981793

  • Shustov 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.

    PubMed 28264616

  • Coiffier 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.

    PubMed 22271479

  • Horwitz 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.

    PubMed 25605745

  • Foss 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.

    PubMed 26965915

  • Foss 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.

    PubMed 25279222

  • Coiffier 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.

    PubMed 24456586

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Romidepsin in people with Peripheral T-cell Lymphoma, run by Celgene at 90 sites in 10 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 10 inclusion and 41 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 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, France, Germany, Spain, United Kingdom and 5 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 13 Aug 2012). 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?

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 (time frame: 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.). 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 NCT00426764, which also lists 7 linked publications.

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 11 Feb 2020.

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