A randomized phase III study in previously untreated patients with biological high-risk CLL: fludarabine and cyclophosphamide (FC) versus FC and low-dose alemtuzumab

Completed

• Conditions: Chronic Lymphocytic Leukemia (CLL); Cancer; Leukaemia

• Registration Number: ISRCTN25180151
• Lead Sponsor: Rigshospitalet (Denmark)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Biological high-risk CLL
2. Patients with symptomatic stage A, symptomatic stage B or stage C
3. Age 18-75 years inclusive
4. Written informed consent

Exclusion Criteria

1. WHO performance status >/= 3, unless related to CLL
2. Intolerance of exogenous protein administration
3. Severe cardiac dysfunction (New York Heart Association [NYHA] classification III-IV)
4. Significant renal dysfunction (serum creatinine >/= 150 micromol/l or creatinine clearance <30 ml/min)
5. Significant hepatic dysfunction (total bilirubin or transaminases >2 times upper limit of normal [ULN]), unless related to CLL
6. Suspected or documented central nervous system (CNS) involvement by CLL
7. Known HIV positivity
8. Active, uncontrolled infections
9. Uncontrolled asthma or allergy requiring systemic steroid treatment
10. Previously treated with chemotherapy, radiotherapy or immunotherapy for CLL
11. History of active cancer during the past 5 years, except non-melanoma skin cancer or stage 0 cervical carcinoma
12. Clinically significant auto-immune hemolytic anemia (AIHA)
13. Female patients who are pregnant or nursing
14. 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. These methods must be applied for the entire protocol treatment period, and for patients treated with alemtuzumab until at least 6 months after the end of alemtuzumab administration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified