EUCTR2005-003018-14-AT进行中（未招募）不适用
Randomized phase III trial comparing early treatment withfludarabine, cyclophosphamide + rituximab versus deferredtreatment in untreated Binet stage A patientswith high risk of progressionCLL 7 protocol of the GCLLSG and FCGC
AKH Vienna0 个研究点目标入组 600 人开始时间: 2006年1月26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
- 600
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) Established diagnosis of B-CLL by NCI criteria (Cheson et al., 1996). Diagnosis will
- •be retrospectively confirmed by an expert review committee. Immunophenotyping
- •should be stored in list mode and one stained blood smear available.
- •2) Binet stage A.
- •3) First diagnosis within 12 months before inclusion in study.
- •4) Start of therapy possible within 28 days after completed risk stratification/
- •randomization.
- •5) No prior chemotherapy, radiation or antibody treatment.
- •6) Age > 18 years.
- •7) Life expectancy > 6 months.
- •8) ECOG performance status 0 - 2.
- •9) Written informed consent of patient and treating physician.
- •10) All parameters for risk stratification present.
- •11) Willingness to accept contraception if randomized to cohort I for the
- •duration of therapy and 12 months thereafter.
- •12) Negative serum pregnancy test one week prior to treatment for premenopausal
- •13) Ability to understand the protocol.
- •14) Possibility of follow up.
- •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
- •1) Age < 18 years.
- •2) ECOG performance status > 2.
- •3) Clinically apparent autoimmune cytopenia, in particular antiglobulin test positive
- •hemolytic anemia (positive antiglobulin test without anemia is not an exclusion
- •4) Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease
- •other than B-CLL prior to the study
- •5) Medical condition requiring the prolonged (estimated to be more than one month) use
- •of oral corticosteroids
- •6) History of anaphylactic reaction following exposure to humanized monoclonal
- •7) Patients with active bacterial, viral or fungal infection
- •8) Known infection with HIV, Hepatitis B or C
- •9) Treatment with any other investigational agent or participating in another trial within
- •30 days prior to entering this study
- •10) Pregnancy and/or nursing
- •11) Concurrent severe diseases which exclude the administration of therapy
- •o heart insufficiency NYHA grade III/IV, LVEF < 50% and or RF <30%,
- •myocardial infarction within the past 6 months prior to study
- •o severe chronic obstructive lung disease with hypoxemia
- •o severe diabetes mellitus
- •o hypertension difficult to control
- •o impaired renal function with creatinine clearance < 70 ml/min according to the
- •formula of Cockroft and Gault
- •o Serum bilirubin > 2 x ULN
- •o Cerebral dysfunction or any other coexisting medical or psychological condition
- •that woud preclude participation in the required study procedures
- •12) Transformation to aggressive B cell malignancy (i.e. diffuse large cell
- •Richter’s syndrome or prolymphocytic leukemia
研究者
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