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 THERAPYESTUDIO EN FASE II, MULTICÉNTRICO Y ABIERTO PARA EVALUAR LA ACTIVIDAD Y TOLERABILIDAD DE ROMIDEPSINA (DEPSIPÉPTIDO,FK228) EN LINFOMA DE CÉLULAS T PERIFERICAS (LCTP) EN PROGRESIÓN O EN RECAIDA DESPUÉS DE UNA TERAPIA SISTÉMICA PREVIA - 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-ES
- Lead Sponsor
- Gloucester Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
•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 ?? T-cell lymphoma, 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 (see Appendix A);
•PD following at least one systemic therapy or refractory to at least one prior systemic therapy;
•Measurable disease according to the IWC criteria (see Appendix B) and/or measurable cutaneous disease;
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix C);
•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
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
•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);
•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:
oCongenital long QT syndrome;
oQTcF interval >480 milliseconds (msec);
oA myocardial infarction within 12 months of study entry;
oOther significant ECG abnormalities including 2nd atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).
oA history of coronary artery disease (CAD), e.g., angina Canadian Class II-IV . In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
oAn 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;
oCongestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Appendix F) and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or MRI;
oA 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);
oHypertrophic cardiomyopathy or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above);
oUncontrolled hypertension, i.e., blood pressure (BP) of =160/95; or
oAny 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 prolongation of the QTcF (see Appendix G);
•Concomitant use of CYP3A4 inhibitors (see Appendix D);
•Concomitant use of warfarin due to a potential drug interaction;
•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:
oHemoglobin <9 g/dL (transfusions and/or erythropoietin are permitted);
oAbsolute neutrophil count (ANC) =1.0 × 109 cells/L [patients with neutropenia (ANC 1–1.5) as a function of their disease may be supported with granulocyte-colony stimulating factor (G-CSF)];
oPlatelet count <100 × 109 cells/L or platelet count <75 × 109 cells/L if bone marrow disease involvement is documented;
oTotal bilirubin >2.0 × upper limit of normal (ULN) or >3.0 × ULN in the presence of demonstrable liver metastases;
oAspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method