EUCTR2006-006228-21-IT进行中（未招募）不适用
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 - ND
适应症
试验速览
- 阶段
- 不适用
- 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 (excludes mycosis fungoides or Se`zary 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; Progressive disease 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 (see Appendix C); Serum potassium ≥3.8 mmol/L and magnesium ≥0.85 mmol/L Negative urine or serum pregnancy test on females of childbearing potential; and All women of childbearing potential must use an effective barrier method of Male patients should use a barrier method of contraception during the treatment period and for at least 3 months thereafter.
- •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); Initiation of corticosteroids during study Concomitant use of any other anti-cancer therapy; 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. o Other significant ECG abnormalities.. o Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV o Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV; 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 o Uncontrolled hypertension o Any cardiac arrhythmia requiring anti-arrhythmic medication; Serum potassium <3.8 mmol/L or serum magnesium <0.85 mmol/L Concomitant use of drugs that may cause a significant prolongation of the QTc or use of CYP3A4 significant or moderate inhibitors Concomitant use of therapeutic warfarin or another anticoagulant Clinically significant active infection; Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; Previous extensive radiotherapy; Major surgery within 2 weeks of study entry (C1D1); Previous allogeneic stem cell transplant; Inadequate bone marrow or other organ function.
研究者
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