EUCTR2005-000309-75-CZActive, not recruitingPhase 1
A randomized phase III study in previously untreated patients with biological high-risk CLL: Fludarabine + cyclophosphamide (FC) versus FC + low-dose alemtuzumab
HOVON CLL Group0 sites300 target enrollmentStarted: May 16, 2007Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
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