EUCTR2006-006228-21-ES进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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