EUCTR2007-007587-21-AT进行中（未招募）1 期
Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) versus Bendamustine and Rituximab (BR) in patients with previously untreated chronic lymphocytic leukemia - CLL10
niversity of Cologne, Sponsor-Quality Management0 个研究点目标入组 550 人开始时间: 2008年11月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
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
- •1.18 years of age or older.
- •2.Confirmed diagnosis of B-CLL.
- •3.Stage Binet C or stage Binet B and A requiring treatment
- •All patients must fulfill the criteria of disease requiring treatment. Disease requiring treatment is defined as:
- •Binet stage B or A plus at least one of the following signs or symptoms:
- •-B symptoms (night sweats, weight loss ? 10% within the previous 6 months, fevers > 38°C or 100.4°F for ? 2 weeks without evidence of infection) or constitutional symptoms (fatigue)
- •-progressive lymphocytosis (lymphocytosis is defined as peripheral lymphocyte count > 5x109/l) (increase > 50% over a 2-month period or doubling of peripheral lymphocyte count < 6 months)
- •-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)or progressive or symptomatic lymphadenopathy
- •marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy.
- •4.WHO performance status of 0-2.
- •5.Life expectancy = 6 months.
- •6.Adequate liver function as indicated by a total bilirubin, AST, and ALT =2x the institutional ULN value, unless directly attributable to the patient’s tumor.
- •7.Willingness of fertile Male and female patients to use an highly effective contraceptive method with a Pearl-Index < 1 (such as implants, injectables, oral contraceptives in combination with an other contraceptive method, some IUDs, sexual abstinence or vasectomised partner) while on study treatment and for a minimum of six months following study therapy
- •8.Signed, written informed consent
- •9.Patient is a) male b)female and ? 2 years after the onset of menopause c) female and < 2 years after the onset of menopause and has a negative serum pregnancy test one week prior treatment.
- •10.Negative serological Hepatitis B test, negative testing of Hepatitis C RNA, negative HIV test within 6 weeks prior to registration.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1.CIRS-Score > 6. or a single score of 4 for one organ category.
- •2.Patients with a 17p deletion detected by FISH (these patients will be treated within the CLL2O or CLL2L protocol of the GCLLSG)
- •3.Creatinine clearance <70ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured after 24h-urine collection. Creatinine Clearance is to be calculated only in patients with serum creatinine = 1.1 mg/dl.
- •4.Any prior CLL specific-chemotherapy and/or radiotherapy and/or immunotherapy (except for prednisolon treatment administered due to very high lymphocyte counts immediately before first FCR or BR treatment).
- •5.Patients who have progressed with more aggressive B-cell cancers such as Richter’s syndrome.
- •6.Active secondary malignancy requiring treatment (except basal cell carcinoma or malignant tumour curatively treated by surgery). or successfully treated secondary malignancies in complete remission more than 5 years before enrollment ).
- •7.History of anaphylaxis following exposure to monoclonal antibodies.
- •8.Active bacterial, viral or fungal infection.
- •9.Medical condition requiring prolonged use (defined as > 1 month) of oral corticosteroids.
- •10.Cerebral dysfunction, legal incapacity.
- •11.Pregnant or nursing women, fertile men or women of childbearing potential not using adequate contraception.
- •12.Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
- •13.Participation in any other clinical trial
研究者
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