Ofatumumab and High-dose Methylprednisolone in Patients With Chronic Lymphocytic Leukemia (CLL)
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be
eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4
week cycles. The primary endpoint is to determine the complete response (CR) to therapy and
the secondary endpoints will assess the safety and tolerability of the regimen, the impact of
the treatment on progression free, treatment free, overall survival, and pharmacokinetics of
ofatumumab. Patients will receive allopurinol for tumor-lysis prophylaxis and antimicrobial
prophylaxis.