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

Completed · Phase 2

Conditions studied: Peripheral T-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT00426764

Run by

Celgene

People needed

131

Starts

2007-06-19

Expected to finish

2018-05-17

Last updated by the study team

2020-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;
• 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.

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;
• 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;

Where it is running

• UCLA Division of Hematology Oncology — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Rocky Mountain Cancer Centers-Aurora — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Georgetown University IRB — Washington D.C., District of Columbia, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Cancer Centers of Florida, PA — Orlando, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Augusta Oncology Associates, P.C. — Augusta, Georgia, United States
• Central Georgia Cancer Care — Macon, Georgia, United States
• Cancer Care and Hematology Specialists of Chicagoland — Arlington Heights, Illinois, United States
• Hematology Oncology Assoc. of IL Orchard Research LLC — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Consultants in Blood Disorders and Cancer — Louisville, Kentucky, United States
• St. Agnes - Medical Center — Baltimore, Maryland, United States
• Center for Cancer And Blood Disorders — Bethesda, Maryland, United States
• Center for Cancer Research CAMC — Bethesda, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Minnesota Oncology Hematology, PA — Burnsville, Minnesota, United States
• St. Joseph Oncology, Inc — Saint Joseph, Missouri, United States
• Arch Medical Services — St Louis, Missouri, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Moore UCSD Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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