Bendamustine Combined with Alemtuzumab in Pretreated Chronic Lymphocytic Leukemia (CLL) – A Phase I/II Trial with Concomitant Evaluation of Safety and Efficacy - BendAlem

Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH0 个研究点开始时间: 2009年1月19日最近更新: 2012年11月12日

适应症

试验速览

暂无简介。

•Male or female patients with CD23+, CD5+, CD19+ light chain monoclonal B-CLL with treatment indication according to IWCLL criteria (Appendix 4)
•1st or greater relapse after fludarabine or any other primary treatment regimen
•Refractory to any previous treatment and simultaneous indication for treatment according to IWCLL criteria (Appendix 4)
•Age 18 years and older
•ECOG status 0 – 2
•Life expectancy > 6 months
•Written informed consent given by the patient
•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 study. Male patients have to use an adequate contraception method for the duration of study treatment and for 6 months following completion of study treatment. Women of childbearing potential have to use an effective method of contraception for the duration of study participation.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•HIV positive or positive for Hepatitis B or C
•Active uncontrolled infection
•Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or to the excipients of any of the applied drugs (e.g. Bendamustine hydrochloride or mannitol)
•Previous treatment with bendamustine
•Treatment with an experimental drug within the previous 2 months
•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.
•Transformation to aggressive B-cell malignancy (e.g. large B-cell lymphoma, Richter's syndrome, or prolymphocytic leukemia (PLL)
•Decreased kidney function with creatinine clearance < 30 ml/min
•Patients with severe co-morbidities or major organ dysfunctions (e.g. known severe liver damage, jaundice)
•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
•Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent, or patients unable to comply with requirements of study protocol.

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