Leukaemia, Lymphoblastic Clinical Trial
Official title:
A Phase II, Open Label, Single Arm, Multicenter Study of Chlorambucil in Japanese Previously Untreated Patients With Chronic Lymphocytic Leukemia
This study is an open-label, single arm, phase II study of chlorambucil in subjects with
previously untreated CLL.
The primary objective is to evaluate the response to chlorambucil in Japanese subjects with
previously untreated CLL.
Secondary objectives are to evaluate efficacy, safety and pharmacokinetics of chlorambucil
in Japanese subjects.
This study is an open-label, single arm, phase II study of chlorambucil in subjects with
previously untreated CLL.
The primary objective is to evaluate the response to chlorambucil in Japanese subjects with
previously untreated CLL.
Secondary objectives are to evaluate efficacy, safety and pharmacokinetics of chlorambucil
in Japanese subjects.
Chlorambucil is an effective and well-tolerated chemotherapeutic agent currently approved
for treatment of chronic lymphocytic leukemia (CLL) in the United States of America (US),
European Union (EU) and other countries globally but not in Japan. Other more aggressive
treatment options such as a combination of fludarabine (F) and cyclophosphamide are
available, but are associated with significantly greater toxicities. The addition of
ofatumumab to chlorambucil offers potentially a more effective therapy, with limited
additional toxicity.
Study OMB110911 has been conducted mainly in the US and EU to evaluate progression-free
survival (PFS) and overall response (OR) in subjects with previously untreated CLL with
ofatumumab in combination with chlorambucil versus (vs.) chlorambucil monotherapy.
The objective of this study is to evaluate overall response of chlorambucil in Japanese
subjects with previously untreated CLL.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment