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 - Depsipeptide in PTC

• Conditions: Progressive or relapsed Peripheral T-Cell Lymphoma (PTCL); MedDRA version: 8.1Level: LLTClassification code 10034624Term: Peripheral T-cell lymphoma unspecified NOS

• Registration Number: EUCTR2006-006228-21-CZ
• Lead Sponsor: Gloucester Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-21
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• Histologically confirmed PTCL NOS, angioimmunoblastic T-cell lymphoma, extranodal NK/T-cell lymphoma nasal type, enteropathy- type T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous gamma delta T-cell lymphoma (excludes mycosis fungoides or Sézary syndrome), transformed mycosis fungoides, hepatosplenic T cell lymphoma, ALCL (ALK-1 negative), or patients with ALK 1 expressing ALCL (ALK-1 positive) who have relapsed disease after ASCT;
• Age =18 years;
• Written informed consent;
• PD following at least one systemic therapy or refractory to at least one prior systemic therapy;
• Measurable disease according to the 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 (magnesium converts to 2.0 mg/dl or 1.7 mEq/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 3 months 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• 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 C1D1 until study drug discontinuation)
o Patients treated with a pulse of steroids must 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:
o Congenital long QT syndrome;
o QTc interval >480 milliseconds (msec);
o Myocardial infarction within 6 months of C1D1. Subjects with a history of myocardial infarction 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;
o Other significant ECG abnormalities including 2nd° atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).
o 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;
o 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;
o 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;
o 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);
o Hypertrophic cardiomyopathy or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above);
o 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.
o Any cardiac arrhythmia requiring anti-arrhythmic medication;
• Serum potassium <3.8 mmol/L or serum magnesium <0.85 mmol/L (magnesium converts to 2.0 mg/dl or 1.7 mEq/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 due to a potential drug interaction. Use of a low dose of warfarin or another 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,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified