Fludarabine/Rituximab combined with escalating doses of Lenalidomide followed by Rituximab/Lenalidomide in untreated chronic lymphocytic leukemia (CLL) – a dose-finding study with concomitant evaluation of safety and efficacy - RevliRit

Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH0 个研究点开始时间: 2008年7月23日最近更新: 2012年5月15日

适应症

试验速览

暂无简介。

•B-CLL (as determined by CD23+, CD5+, CD19+)
•Treatment indication as defined by the NCI Workshop criteria
•ECOG performance status 0-2
•No previous treatment of the CLL by chemotherapy, radiotherapy (except localized radiotherapy of 1 lymphatic area) or immunotherapy
•Life expectancy > 6 months (except prognosis due to high risk CLL)
•Patient's written informed consent
•Women of non-childbearing potential, or women of childbearing potential with adequate contraception. Men using effective contraception.
•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

•Active bacterial, viral or fungal infection
•Positivity for HIV, Hepatitis B or C
•Reduced organ functions and bone marrow dysfunction not due to CLL
•Creatinine clearance of below 30 ml/min
•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 angina
•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.

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