Conditions: Leukaemia, Lymphoblastic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 5
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 treatment cycles

Interventions: intervention 1: chlorambucil, tablets
Intervention descriptions: intervention 1: 2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles

Protocol document: