Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

An Open-label Phase I Study of Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of ofatumumab monotherapy in Japanese follicular lymphoma (FL) or chronic lymphocytic leukemia (CLL) patients. subject will receive ofatumumab 8 weekly infusions.

INCLUSION CRITERIA:

• Signed Informed Consent.
• Histologically confirmed relapsed or refractory CD20 positive FL grade 1-3a and 1 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or CD5, CD19, CD20 and CD23 positive relapse or refractory CLL.
• Subjects must have adequate blood, liver, and kidney function.
• Subjects who passed the provided periods from the last anti-cancer treatments at screening
• ECOG Performance Status of 0-2
• Life expectancy more than 24 weeks at screening

EXCLUSION CRITERIA:

• Current and past malignancy other than FL and CLL within 5 years prior to screening.
• Known Richter's transformation
• Previous autologous stem cell transplantation within 24 weeks prior to screening
• Previous allogeneic stem cell transplantation
• Known CNS involvement
• History of significant cerebrovascular disease
• Current cardiac disease requiring medical treatment
• Chronic or ongoing active infectious disease requiring systemic treatment
• Patients with pleural effusion or ascites detectable by physical examination
• Positive serology test for any of HBsAg, anti-HBc or anti-HCV
• Known HIV positive
• Pregnant or lactating women
• Women of childbearing potential and male patients not willing to use adequate contraception