Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients
Condition: Leukaemia, Lymphocytic, Chronic
MeSH terms: Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ofatumumab 500mg; Ofatumumab 1000mg; Fludarabine; Cyclophosphamide
Intervention description: Ofatumumab 500mg or should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 6½ hours.Infusions should be given every 4 weeks until a total of 6 infusions has been given.; Ofatumumab 1000mg or should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 6½ hours.Infusions should be given every 4 weeks until a total of 6 infusions has been given.; Fludarabine (25 mg/m2) should be administered as an IV infusion daily, Days 2 through 4 of Course 1, and Days 1 through 3 of Courses 2 through 6, every 4 weeks for 6 courses; Cyclophosphamide (250 mg/m2) should be administered as an IV infusion daily, Days 2 through 4 of Course 1, and Days 1 through 3 of Courses 2 through 6, every 4 weeks for 6 courses.
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Ofatumumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: B-cell; cyclophosphamide; fludarabine; Chronic Lymphocytic Leukemia; Ofatumumab

Summary:

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

Eligibility criteria:

        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.