An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma (FL).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Classified as Responders at Visit 26 (3 Months After Last Infusion of Ofatumumab)
An Independent Review Committee (IRC) assessed overall best response based on standardized response criteria for non-Hodgkin's Lymphomas (NHL) and classified the participants as responders and non-responders. Responders included participants with complete remission (CR; complete disappearance of all detectable clinical and radiographic evidence of disease), complete remission unconfirmed (CRu; more than a 75% decrease in lymph node [LN] size compared to baseline), and partial response (PR; >=50% decrease in LN size and evidence of new lesions).
Maximum of 23 months after the start of treatment
GSK Clinical Trials
United States: Food and Drug Administration