Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients

An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With Fludarabine and Cyclophosphamide, in Patients With Previously Untreated B-cell CLL

To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with chemotherapy in previously untreated patients with B-CLL

Inclusion Criteria:

1. Patients with active B-CLL and with an indication for treatment
2. Age ≥ 18 years
3. Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out

Exclusion Criteria:

1. Any previous treatment for B-CLL or any other treatments that can be considered active against B-CLL

2. Glucocorticoid unless given in doses ≤ 10 mg /day for other indications than B-CLL (e.g. asthma)

3. Known transformation of B-CLL

4. Known CNS involvement of B-CLL

5. Past or current malignancy, except for:

   1. Cervical carcinoma Stage 1B or less
   2. Non-invasive basal cell and squamous cell skin carcinoma
   3. Malignant melanoma with a complete response of a duration of > 10 years
   4. Other cancer diagnoses with a complete response of a duration of > 5 years

6. Chronic or current infectious disease requiring systemic treatment

7. Clinically significant cardiac disease

8. Significant concurrent, uncontrolled medical condition

9. History of significant cerebrovascular disease

10. Known HIV positive

11. Positive serology for hepatitis B, unless due to vaccination

12. Leukapheresis, except as a safety measure before chemotherapy

13. ECOG Performance Status of 3 or 4

14. Patients who at the time of inclusion are not expected to be able to complete the ofatumumab-FC regimen

15. Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 1

16. Current participation in any other interventional clinical study

17. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)

18. Breast feeding women or women with a positive pregnancy test at Visit 1

19. Women of childbearing potential not willing to use adequate contraception for up to one year after last dose of ofatumumab. Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the USA the use of a double barrier method is also considered adequate.