An Open Label Pilot study with oral fludarabine, oral cyclophosphamide and CAMPATH 1H (FCC) for patients with refractory or Relapsed B cells Chronic Lynphocytic Leukaemia - FCC
- Conditions
- B-cells CLL Chronic Lymphocytic LeukaemiaMedDRA version: 9.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2005-000121-30-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
signed informed consent
male or female > 17 years
WHO performance status 0-II
life expectancy at least 6 months
confirmation of LLC-B
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
Exclusion Criteria
No previous chemotherapy or immunotherapy
Previous CAMPATH 1H admistered in combination with chemotherapy
HIV HBV HCV positive
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