A randomized phase III study in previously untreated patients with biological high-risk CLL: Fludarabine + cyclophosphamide (FC) versus FC + low-dose alemtuzumab.
- Conditions
- Chronic Lymphocytic Leukemia
- Registration Number
- NL-OMON25345
- Lead Sponsor
- Dr. C.H. GeislerRigshospitaletDept. of Hematology (L 4042)Blegdamsvej 9DK-2100 CopenhagenDenmarkTel: 0045 35451146Fax: 0045 35454283e-mail:geisler@rh.dk
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
1. Biological high-risk CLL;
2. Patients with symptomatic stage A, symptomatic stage B or stage C;
Exclusion Criteria
1. WHO performance status >= 3, unless related to CLL;
2. Intolerance of exogenous protein administration;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (i.e. time from registration to disease progression, relapse or death due to CLL whichever occurs first).
- Secondary Outcome Measures
Name Time Method 1. Event free survival (i.e. time from registration to induction failure, progression, relapse or death whichever occurs first); the time to failure of patients with induction failure is set at one day;<br /><br>2. Clinical, flow cytometric and molecular response rate;<br /><br>3. Overall survival;<Br><br>4. Disease free survival (i.e. time from CR to relapse);<br /><br>5. Toxicity.