Phase II pilot trial to evaluate the efficacy and safety of a first-line combined therapeutic approach for young (> = 60 years old) CLL patients with advanced and progressive disease stratified according to the biological prognostic features. GIMEMA LLC0405. EudraCT Number 2005-002476-15.
- Conditions
- CLL patients (diagnosis of CLL according to NCI criteria) with the following characteristics: Advanced stage or progressive disease with at least 2 clinical features of activity. Previously untreated patients. Age <=18 to >=60.MedDRA version: 14.1Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-002476-15-IT
- Lead Sponsor
- G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method