EUCTR2008-001421-34-DE进行中（未招募）不适用
Phase II Trial of Combined Immunochemotherapy withFludarabine, Mitoxantrone, Cyclophosphamide andAlemtuzumab (FMC-Alemtuzumab) in Patients withPreviously Treated or Untreated T-Prolymphocytic Leukemia - TPLL2
niversity of Cologne, Sponsor-Quality Management0 个研究点目标入组 16 人开始时间: 2009年10月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
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
- •Untreated patients with T-prolymphocytic leukemia (T-PLL) according to WHO criteria
- •or pretreated patients (max. two previous treatment) with T-PLL
- •Age = 18 years, ? 19 years for Austria
- •WHO performance status of 0-2
- •Life expectancy > 6 months
- •CIRS score ? 6
- •Left ventricular ejection fraction =50% confimed by echo-cardiogram performed < 6 months before inclusion to the trial and after the end of a possible anthracycline-contai-ning pretreatment
- •Adequate liver function as indicated by a total bilirubin, AST and ALT ? 2 the institional ULN value, unless directly attributable to the T-PLL
- •Creatinine clearance ? 60 ml/min calculated according to the formula of Cockcroft and Gault
- •Seronegativity for HIV, HBV or HCV confirmed by serolo-gical testing within 6 weeks prior to registration
- •Willingness of fertile male and female patients to use an highly effective contraceptive method with a Pearl-Index < 1 during and at least six months after the end of the study treatment (e.g. implants, injectables, oral contra-ceptives in combincation with another contraceptive method, some IUDs, sexual abstinence or vasectomised partner)
- •Negative serum preganacy test one week prior to treat-ment (required for female patients before and <2 years after onset of menopause)
- •Patient's written informed consent
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Clinically significant auto-immune cytopenia or clinically significant hemolytic anaemia with suspicion of an immune origin, even if the Coombs test is negative
- •Active secondary malignancy requiring treatment (except basal cell carcinoma or tumor curatively treated by surgery)
- •Medical condition requiring prolonged use of oral corticosteroids (> 1 month)
- •Cerebral dysfunction, legal incapacity
- •Any circumstance at the time of study entry that would preclude completion of the study and required follow-up
- •Active infection or severe infection (WHO 4th degree) within the last three months before inclusion to the study
- •Participation in any other clinical trial during this study
- •Known hypersensitivity to any of the study medications (Fludarabine, Cyclophospha-mide, Mitoxantrone or Alemtuzumab)
- •Patients who have already received more than 60% of the recommended maximum cumulative dose of an anthracycline (Epirubicine, Adriamycine or Mitoxantrone).
- •This maximum cumulative dose is defined for the individual substances as follows:
- •- Epirubicin 900 mg/m²
- •- Daunorubicin 550 mg/m², (or 400 mg/m² if the patient received mediastinal irradiation)
- •- Adriamycine (Doxorubicine) 550 mg/m²
- •- Mitoxantrone 200 mg/m²
- •Patients who already received Fludarabine in combination with Cyclophosphamide or Mitoxantrone during the last 6 months before inclusion into the trial.
- •Patients who received prior treatment with Alemtuzumab alone or in combination with a purine analogue and who did not achieve a PR that lasted at least 6 months
- •Patients who are employees of the Sponsor (University of Cologne) or the study sites.
研究者
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进行中（未招募）
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Patients who suffer from T-Prolymphocytic leukemia and have received none or one chemotherapy so far will be treated with Fludarabine, Cyclophosphamide, Mitoxantrone and Alemtuzumab.ntreated patients with T-prolymphocytic leukemia (T-PLL) according to WHO criteria or pretreated patients (max. one previous treatment) with T-PLL.EUCTR2008-001421-34-ATniversität zu Köln16
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