An Open-label Phase I Study of Ofatumumab (GSK1841157) in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
- 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
- ECOG Performance Status of 0-2
- Life expectancy more than 24 weeks at screening
- 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