A Phase I/II, a Single Arm, Open-label Study of Ofatumumab (GSK1841157) in Patients With Previously Treated Chronic Lymphocytic Leukemia
Ofatumumab is an IgG1κ fully human monoclonal antibody (mAb) that specifically recognizes an
epitope on the human differentiation antigen CD20 molecule. In vitro and in vivo studies
demonstrated that ofatumumab depletes CD20 positive (CD20+) B cells through
complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity
(ADCC), which results in the antitumour effect.
This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of
ofatumumab monotherapy in chronic lymphocytic leukemia (CLL) patients. Ofatumumab will be
administered intravenously at the first dose of 300mg followed by 7 weekly infusions of
2000mg, followed by 4 infusions of 2000mg at every 4 weeks.
Primary objective of the study (Part A) is to evaluate tolerability, and the study (Part B)
is to assess overall response rate in CLL population.
10 subjects will be enrolled into this study. Subjects will be followed for 48 weeks.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With a Dose-limiting Toxicity (DLT)
A DLT was defined as the following toxicological findings, according to the Common Terminology Criteria for Adverse Events (AE) v3.0: any treatment-related Grade (G) >=3 non-hematotoxic AE, occurrence of G3 infusion reaction (treatment-related AE) at the day of infusion in a participant who received pre-medication or appropriate management during infusion (glucocorticoid) (the severity of the AE must have remained as >= G3 until the next day); and any of following: >= G4 hematotoxic treatment-related AEs (neutropenia lasting 7 days or more, febrile neutropenia).
Up to Week 8
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
Japan: Ministry of Health, Labor and Welfare
112758
NCT01077622
September 2009
April 2011
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