EUCTR2004-002787-15-CZ进行中（未招募）不适用
Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FC-R) versus chemotherapy with Fludarabine and Cyclophosphamide (FC) alone in patients with previously untreated chronic lymphocytic leukaemia.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 817
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
- •B-CLL confirmed according to NCI Working Group criteria [1]
- •Binet stage C as well as Binet stage B requiring treatment
- •All patients must fulfill the criteria of disease requiring treatment. Disease requiring treatment is defined as:
- •Binet stage C
- •Binet stage B plus at least one of the following signs or symptoms:
- •- B symptoms (night sweats, weight loss > or = 10% within the previous 6 months, fevers > 38°C or 100.4°F for > or = 2 weeks without evidence of infection) or constitutional symptoms (fatigue)
- •- Continuous progression (doubling of peripheral lymphocyte count < 6 months AND absolute lymphocyte count > 50 G/l)
- •- evidence of progressive marrow failure as manifested by the development / worsening of anemia and/or thrombocytopenia
- •- massive, progressive or painful splenomegaly or hypersplenism
- •- massive lymph nodes or lymph node clusters (> 10 cm in longest diameter), danger of organ complications through large lymphomas (e.g. vascular compression, e.g. tracheal narrowing) or progressive lymphadenopathy
- •- Occurrence of symptomatic hyperviscosity problems at leucocyte counts > 200 G/l (symptomatic leucostasis)
- •No previous treatment of the CLL by chemotherapy, radiotherapy or immunotherapy.
- •Alkaline phosphatase and transaminases = 2 x ULN
- •A negative serum pregnancy test one week prior to treatment must be available both for pre-menopausal women and for women who are < 2 years after the onset of menopause.
- •Willingness to use contraception for the entire duration of the treatment and 2 months thereafter
- •Patient's written informed consent
- •Age > or = 18 years
- •Life expectancy > 6 months
- •ECOG performance status 0-1
- •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 567
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 243
排除标准
- •Stage Binet A
- •Clinically significant auto-immune cytopenia, Coombs-positive haemolytic anaemia as judged by the treating physician.
- •Active second malignancy currently requiring treatment (except basal cell carcinoma or tumour treated curatively by surgery)
- •Pregnancy,and/or nursing
- •Concomitant disease requiring prolonged use of glucocorticoids (> 1 month)
- •Known hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any of the study drugs
- •CIRS score > 6
- •Cerebral dysfunction which makes it impossible to perform chemotherapy
- •Transformation to aggressive B-cell malignancy (eg diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukaemia) .
- •Active bacterial, viral or fungal infection. Although testing for hepatitis B is not mandatory, this should be considered for all patients considered at high risk of hepatitis B infection and in endemic areas. Patients with any serological evidence of current or past hepatitis B infection are excluded unless the serological findings are clearly due to vaccination.
- •Total bilirubin > 2 x ULN
- •Creatinine clearance < 70 ml/min calculated according to the formula of Cockcroft and Gault
- •Any coexisting medical or psychological condition that would preclude participation in the required study procedures.
- •Treatment with any other investigational agent, or participating in another clinical trial within 30 days prior to entering this study.
研究者
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