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

• Status: Completed
• Trial end date: 2009-11-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; Ofatumumab

Criteria

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