Phase II study of the combination of Lenalidomide and Alemtuzumab as consolidation in patients who responded to a previus chemotherapeutic regimen administered for relapsed or refractory Chronic Lymphocytic Leukemia (CLL) - len-cam
- Conditions
- CLL patientsMedDRA version: 9.1Level: LLTClassification code 10008958Term: Chronic lymphocytic leukaemia
- Registration Number
- EUCTR2008-001823-71-IT
- Lead Sponsor
- Associazione Malattie Sangue ONLUS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- signed written informed consent
- age 18 years or older
- WHO performance status 0-II
- life expectancy > 6 months
- confirmation BCLL
- no major infection
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- any serious medical condition or psychiatric illness
- pregnant or lactating women
- active secondary malignancy
- negativity for CD52 marker
- previous autologous or allogeneic stem cell transplant
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to identify the Maximum Tolerated Dose of Lenalidomide in combination with Alemtuzumab 30mg /weekly;Secondary Objective: - efficacy and tolerability of the combination Lenalidomide and Alemtuzumab;Primary end point(s): to identify maximum tolerated dose of Lenalidomide with Alemtuzumab
- Secondary Outcome Measures
Name Time Method