Phase II study of the combination Bendamustine and sc Alemtuzumab for patients with refractory or relapsed B-cell chronic lynphocytic leukemia - BEN-CAM
- Conditions
- patients whit LLCMedDRA version: 9.1Level: LLTClassification code 10008958Term: Chronic lymphocytic leukaemia
- Registration Number
- EUCTR2008-001824-30-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
-age 18 years or older
- WHO status 0-II
- life expectancy > 6 monts
- relapsed or refractory patients after treatment including alkylatin agents or purine analogs or monoclonal antobodies (Rituximab)
- correct renal and liver function
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
- mo concomitant treatment with chemotherapy or immunotherapy
- previous Alemtuzumab administered
- negativity for the CD52+ marker
- HIV positivity
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