Leukaemia, Lymphocytic, Chronic Clinical Trial
Official title:
A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia
This is an open-label study to evaluate tolerability, safety, efficacy and pharmacokinetic profile of ofatumumab in combination with chlorambucil in Japanese patients with previously untreated Chronic Lymphocytic Leukemia (CLL).
This is an open-label study to evaluate tolerability, safety, efficacy and pharmacokinetic
profile of ofatumumab in combination with chlorambucil in Japanese patients with previously
untreated Chronic Lymphocytic Leukemia (CLL). Ofatumumab will be infused intravenously at
Day 1 (300 mg) and Day 8 (1000 mg) in the first 28-day cycle, followed by infusions of 1000
mg at the first day of each 28-day cycle. Chlorambucil will be given 10 mg/m2 at Day 1-7 in
each 28-day cycle.
The primary objectives are to evaluate tolerability and overall response rate (ORR) of
ofatumumab with chlorambucil for previously untreated (frontline) CLL.
Secondary objectives include to evaluate complete remission (CR) rate, progression free
survival (PFS), overall survival (OS), time to response, duration of response, time to next
therapy, incidence and severity of adverse events and serious adverse events, incidences of
grade 3 and 4 infections and myelosuppression (anemia, neutropenia, thrombocytopenia), and
pharmacokinetics of ofatumumab and chlorambucil.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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