EUCTR2008-001506-16-FR进行中（未招募）1 期
Diffuse large B cell non-hodgkin's lymphoma in the vulnerable/frail elderly. A multicentrix randomized phase II trial with emphasis on geritaric assesment and quality of life. - FRAIL 06
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Age 70 years and older
- •Diffuse large B cell lymphoma NHL CD20 positive according to the WHO classification (Harris 1999) including all morphological and clinical variants and excluding Burkitt-like lymphoma (presence of small cells in the bone marrow biopsy is allowed)
- •Previously untreated
- •Ann Arbor stages II, III, IV
- •Performance status 0-3
- •Presence of at least one measurable target lesion = 1.1 cm conforming to the IWC criteria
- •Patients in poor physiological status (all criteria will be checked during registration, patients who fulfill at least one of these following criteria will be considered in poor physiological status):
- •a. Performance status = 3 (WHO scale)
- •b. Cardiac evaluation: clinical evaluation and measurement of left ventricular ejection fraction that do not allow doxorubicin administration (< 50% whatever the method of calculation used)
- •c. Renal function: creatinine clearance < 50 ml/mn calculated according to the Cockroft-Gault equation (Cockroft 1976) : Creatinine clearance =K x (140-age) x(weight in kg)/serum creatinine (µmol/l) with K = 1.23 in men ; K = 1.04 in women
- •d. Hepatic function: serum bilirubine > 30 mmol/l
- •e. Any history of concomitant severe disease that would preclude patients being subjected to CHOP chemotherapy
- •Blood counts: neutrophils > 0.75 x 109/l and platelets > 50 x 109/l
- •Prior written patient informed consent must be given according to ICH/EU GCP, and national/local regulations (English and French versions are available in appendix 2 and 3)
- •For France only : Patients affiliés à un régime de sécurité sociale
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •Left ventricular ejection fraction ?35% (whatever the method used)
- •Previous history of anthracycline administration with cumulated dose over either 240 mg/m² of doxorubicin or 400 mg/m² of 4-epidoxoubicin
- •Documented history of congestive heart failure, serious arrhythmia or myocardial infarction (within 6 months)
- •Documented history of allergy to eggs or egg products
- •Presence of cerebral and meningeal involvement
- •Presence of active infection
- •Serologic profile of active viral hepatitis B or C
- •MabThera contra-indication: Hypersensitivity to the active substance or to any of the excipients of the product or to murine proteins
- •Previous or concurrent second malignant solid tumor (except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix) which have been treated within the previous 5 years
- •Known HIV positivity
- •Patient unable to receive either R-COP or R-COPY schedules
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Participation at the same time in another study in which investigational drugs are used in the thirty days before the randomizatuion.
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