EUCTR2004-001012-32-DE进行中（未招募）不适用
A single agent Phase II study of depsipeptide (FK228) in the treatment of Cutaneous T-cell lymphoma - Depsipeptide in CTC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •Males or non-pregnant females aged ?18 years.
- •Histologically confirmed diagnosis of CTCL, including mycosis fungoides and Sézary syndrome.
- •Patients with CTCL stages IIa, IIb, III and IVa
- •Patients with CTCL stage Ib who have relapsed following previous therapy and where, in the investigator’s opinion, the potential benefit of treatment with FK228 outweighs the possible risks.
- •Patients who have failed standard skin-directed therapy and have had at least one course of systemic therapy, such as interferon, which they have been deemed to have failed.
- •Anticipated life expectancy greater than six months.
- •Written informed consent to participate in the study.
- •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
- •ECOG Performance Status > 1 (see Appendix H).
- •Patients who have not received at least 1 course of prior systemic therapy for CTCL.
- •Visceral involvement i.e. Stage 4b disease (lymphadenopathy is allowed).
- •Patients with known cardiac abnormalities such as:-
- •Congenital long QT syndrome
- •QTc interval > 480 milliseconds
- •Any cardiac arrhythmia requiring anti-arrhythmic medication.
- •Patients who have had a myocardial infarction within 12 months of study entry.
- •Patients who have a history of coronary artery disease (CAD) e.g. angina Canadian class II to IV (Appendix N). In any patient in whom there is doubt, the patient should have a stress imaging study and exercise ECG and, if abnormal, angiography to define whether or not CAD is present.
- •Patients with an ECG recorded at screening showing evidence of cardiac ischaemia (ST depression of ?2 mm). If in any doubt, the patient should have a stress imaging study and exercise ECG and, if abnormal, angiography to define whether or not CAD is present.
- •Patients with congestive heart failure that meets New York Heart Association class II to IV definitions (Appendix O) and/or ejection fraction <40% by multiple gated acquisition (MUGA) scan or <50% by echocardiogram and/or magnetic resonance imaging (MRI)
- •Patients with a 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).
- •Patients with hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above).
- •Patients with uncontrolled hypertension, i.e. ?160/95 mmHg.
- •Concomitant use of any anti-cancer therapy. (For study eligibility, a one month washout period is required before treatment with depsipeptide is started for patients who have received radiotherapy or psoralen plus ultraviolet A (PUVA) therapy.)
- •Concomitant use of warfarin.
- •Concomitant use of any investigational agent.
- •Use of any investigational agent within 4 weeks before treatment with depsipeptide is started.
- •Concomitant use of drugs which may cause a prolongation of the QTc interval. (For study eligibility, a washout period of at least 5 half-lives must elapse before treatment with depsipeptide is started. A list of half lives is provided in Appendix F.)
- •Patients with a potassium level of <3.5 mmol/L and a magnesium level of <0.8 mmol/L.
- •Clinically significant active infection.
- •Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •Inadequate bone marrow or other organ function, as evidenced by:
- •ounsupported haemoglobin <9.0 g/dL (transfusions and/or erythropoietin are permitted);
- •oabsolute neutrophil count (ANC) oplatelet count <100 x 109/L;
- •ototal bilirubin >1.25 x upper limit of normal (ULN) for institution;
- •oaspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN, serum creatinine >2 x ULN for age and sex.
- •Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin or cervical epithelial neoplasm [CIN1, carcinoma in situ] that has been treated curatively).
- •Any significant medical or psychiatric condition that might prevent the patient from complying with all study proced
研究者
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