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
- Conditions
- ntreated chronic lymphocytic leukaemia (B-CLL)MedDRA version: 9.1Level: LLTClassification code 10003946Term: B-Lymphocytic, CLL (Kiel Classification)
- Registration Number
- EUCTR2008-001430-27-AT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
• B-CLL (as determined by CD23+, CD5+, CD19+)
• Treatment indication as defined by the NCI Workshop criteria
• Age =18
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method