EUCTR2005-001502-11-AT进行中（未招募）不适用
CHAIROS” – Early brief intensification by chemoimmunotherapy with FCR followed by FR and Rituximab maintenance in chemonaive patients with B-CLL – A phase II study - CHAIROS
适应症
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
- 40
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 (as determined by CD23+, CD5+, CD19+, CD20+)
- •Treatment indication as defined by the NCI Workshop criteria (see append
- •5 and Ref 10)
- •ECOG performance status 0-2
- •No previous treatment of the CLL by chemotherapy, radiotherapy or
- •immunotherapy
- •Life expectancy > 6 months
- •Patient's written informed consent
- •Patient using a reliable means of contraception (e.g. physical barrier,
- •contraceptive pill or patch, spermicide and barrier, or IUD) for the duration
- •of the treatment including 2 months thereafter
- •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
- •Active bacterial, viral or fungal infection
- •Positivity for HIV, Hepatitis B or C
- •positive Coombs Test and/or autoimmune hemolytic anemia
- •reduced organ functions and bone marrow dysfunction not due to CLL
- •creatinine clearance of below 30 ml/min (calculation of crea. clearance:
- •appendix 6)
- •Patients with a history of other malignancies within 2 years prior to study
- •entry, except for adequately treated carcinoma in situ of the cervix; basal
- •or squamous cell skin cancer; low grade, early stage localized prostate
- •cancer treated surgically with curative intent; good prognosis DCIS of the
- •breast treated with lumpectomy alone with curative intent.
- •Patients with medical co-morbid conditions that would require long term
- •use (> 1 month) of systemic corticosteroids during study treatment
- •Patients with a history of severe cardiac disease; e.g. NYHA Functional
- •Class III or IV heart failure, myocardial infarction within 6 months,
- •ventricular tachyarrhythmias requiring ongoing treatment, or unstable
- •Other known co-morbidity with the potential to dominate survival
- •Transformation to aggressive B-cell malignancy (e.g., large B-cell
- •lymphoma, Richter's syndrome, or prolymphocytic leukemia (PLL)
- •Hypersensitivity with anaphylactic reaction to humanised monoclonal
- •antibodies or any of the applied drugs
- •Pregnant or breast feeding women
- •Any co-existing medical or psychological condition that would preclude
- •participation in the study or compromise ability to give informed consent.
研究者
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