The Phase III chronic lymphocytic leukemia (CLL) front line chlorambucil combination study is an open-label, parallel-arm study that will include 444 patients with previously untreated CLL. Patients in the study will be randomized to receive ofatumumab in combination with chlorambucil or chlorambucil alone. Patients receiving ofatumumab in combination with chlorambucil will receive one infusion of ofatumumab at 300mg, one infusion at 1,000mg a week later, followed by up to 11 monthly infusions at 1,000mg. Patients will be evaluated for disease status one month following last treatment then every three months for five years.
The primary objective of the study is to evaluate the progression free survival of ofatumumab in combination with chlorambucil therapy versus chlorambucil therapy alone for the treatment of front line CLL.
The Phase II CLL ofatumumab retreatment and maintenance treatment study will examine the retreatment and maintenance treatment of refractory CLL patients who participated in the ongoing Phase III CLL study and had disease progression following at least an objective response or stable disease during a 24-week treatment period of ofatumumab.
Eligible patients will receive one infusion of ofatumumab at 300mg followed by seven once weekly infusions at 2,000mg. Maintenance treatment will consist of 24 once monthly infusions of 2,000mg of ofatumumab. The primary objective of this study is to estimate the proportion of objective responses over 52 weeks.
The Phase II non-Hodgkin’s lymphoma (NHL) ofatumumab retreatment and maintenance study will examine the retreatment and maintenance treatment of refractory follicular NHL patients who participated in the ongoing Phase III NHL study and had disease progression following at least six months objective response to or stable disease on ofatumumab.
Eligible patients will receive one infusion of ofatumumab at 300mg followed by seven once weekly infusions at 1,000mg. Maintenance treatment will consist of one 1,000mg infusion every two months for two years. The primary objective of this study is to evaluate the safety of ofatumumab retreatment and maintenance treatment.
The Phase I study in Japan is an open-label study that will include a maximum of 12 patients with relapsed/refractory follicular NHL and at least one CLL patient who will be divided into two cohorts of three or six patients each. Patients will receive one infusion of ofatumumab at 300mg followed by seven weekly infusions of 500 or 1,000mg of ofatumumab. Safety at the 500mg dose level of ofatumumab will be examined before progressing to the 1,000mg dose level. The primary objective of the study is to evaluate the safety and tolerability of ofatumumab in Japanese refractory follicular NHL and CLL patients. The primary endpoint of the study is safety.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.