EUCTR2009-010998-20-GB进行中（未招募）不适用
Attenuated dose Rituximab with ChemoTherapy In CLL:A randomised, phase IIB trial in previously untreated patients with Chronic Lymphocytic Leukaemia (CLL) tocompare fludarabine, cyclophosphamide and rituximab (FCR) with FC, mitoxantrone and low dose rituximab (FCM-miniR) - ARCTIC
eeds Teaching Hospitals NHS Trust0 个研究点开始时间: 2009年4月16日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •At least 18 years old.
- •B-CLL with a characteristic immunophenotype.
- •Binet Stages B, C or Progressive Stage A.
- •Requiring therapy by the IWCLL criteria in that they must have at least one of the following:
- •i) Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia.
- •ii) Massive (ie, 6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
- •iii) Massive nodes (ie, 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
- •iv) Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months as long as the lymphocyte count is over 30x109/L.
- •v) A minimum of any one of the following disease-related symptoms must be present:
- •(a) Unintentional weight loss more than or equal to 10% within the previous 6 months.
- •(b) Significant fatigue (ie, Eastern Cooperative Oncology Group PS 2 or worse; cannot work or unable to perform usual activities).
- •(c) Fevers of greater than 38.0°C for 2 or more weeks without other evidence of infection.
- •(d) Night sweats for more than 1 month without evidence of infection.
- •No prior therapy for CLL.
- •World Health Organisation (WHO) performance status (PS) of 0, 1 or 2.
- •Able to provide 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior therapy for CLL.
- •Active infection.
- •Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanised monoclonal antibodies.
- •Pregnancy, lactation or women of child-bearing potential unwilling to use medically approved contraception whilst receiving treatment.
- •Men whose partners are capable of having children but who are not willing to use appropriate medically approved contraception during the study, unless they are surgically sterile.
- •CNS involvement with CLL.
- •Mantle cell lymphoma.
- •Symptomatic cardiac failure not controlled by therapy or unstable angina not adequately controlled by current therapy (in patients with a significant cardiac history the left ventricular function should be assessed and patients with severe impairment should be excluded).
- •Other severe, concurrent diseases or mental disorders.
- •Known HIV positive.
- •Patient has active or prior Hepatitis B or C.
- •Active secondary malignancy excluding basal cell carcinoma.
- •Persisting severe pancytopenia (neutrophils <0.5 x 109/l or platelets <50 x 109/l) or transfusion dependent anaemia unless due to direct marrow infiltration by CLL.
- •Active haemolysis (patients with haemolysis controlled with prednisolone at a dose 10mg or less per day can be entered into the trial).
- •Patients with a creatinine clearance of less than 30ml/min (either measured or derived by the Cockcroft formula).
研究者
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