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 (CLL)
- Registration Number
- EUCTR2005-000309-75-CZ
- Lead Sponsor
- HOVON CLL Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
•Biological high-risk CLL*
•Patients with symptomatic** stage A, symptomatic** stage B or stage C (see appendix B)
•Age 18-75 years inclusive
•Written informed consent
* Biological high risk is defined as: ? 98 % homology of IgVH genes with germ-line sequences and/or FISH with 17p deletions and/or 11q deletions and/or trisomy 12.
** Symptomatic CLL is defined according to the NCI criteria for active disease (Cheson et al. 1996).
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
•WHO performance status ? 3 (see appendix E), unless related to CLL
•Intolerance of exogenous protein administration
•Severe cardiac dysfunction (NYHA classification III-IV,)
•Significant renal dysfunction (serum creatinine ? 150 ?mol/l or creatinine clearance < 30 ml/min)
•Significant hepatic dysfunction (total bilirubin or transaminases > 2 times ULN), unless related to CLL
•Suspected or documented CNS involvement by CLL
•Known HIV positivity
•Active, uncontrolled infections
•Uncontrolled asthma or allergy requiring systemic steroid treatment
•Previously treated with chemotherapy, radiotherapy or immunotherapy for CLL
•History of active cancer during the past 5 years, except non-melanoma skin cancer or stage 0 cervical carcinoma
•Clinically significant auto-immune hemolytic anemia (AIHA)
•Female patients who are pregnant or nursing
•Male and female patients of reproductive potential who are not practicing effective means of contraception: These include oral contraceptives, intrauterine device, depot injection of gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot plaster.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To assess the effect of the addition of alemtuzumab s.c. to 6 courses of oral FC in terms of progression free survival <br>•To assess the effect of the addition of alemtuzumab s.c. to 6 courses of oral FC in terms of the secondary endpoints <br>•To assess the safety of the addition of alemtuzumab s.c. to 6 courses of oral FC with respect to the incidence of severe opportunistic infections (CMV reactivation, CMV disease, Herpes simplex and Herpes zoster infections, EBV reactivation, deep mycosis, mycobacterial infections, other infections) and infections due to neutropenia<br>;Secondary Objective: ;Primary end point(s): •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