Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma

Summary An international, Phase II trial was conducted to assess two doses of ofatumumab, a human CD 20 monoclonal antibody, combined with cyclophosphamide (750 mg/m 2 ), doxorubicin (50 mg/m 2 ), prednisone (100 mg days 3–7) and vincristine (1·4 mg/m 2 ) (O‐ CHOP ), as frontline treatment for follicular lymphoma ( FL ). 59 patients with previously untreated FL were randomized to ofatumumab 500 mg ( n  = 29) or 1000 mg ( n  = 30) day 1, with CHOP on day 3 every 3 weeks for six cycles. Median duration of FL was 0·1 years for both dose groups; 34% and 38% of patients had high‐risk Follicular Lymphoma International Prognostic Index ( FLIPI ) scores in the 500‐ and 1000‐mg dose groups, respectively. Overall response rate was 90% for the 500‐mg group and 100% for the 1000‐mg group. 62% of patients achieved complete response ( CR )/unconfirmed CR ( CR u). 76% of patients with FLIPI score 3–5 attained CR / CR u. Longer follow‐up time is needed for analysis of survival end points. The most common Common Terminology Criteria grade 3–4 investigator‐reported adverse events were leucopenia (29%) and neutropenia (22%). No deaths have been reported. O‐ CHOP was safe and efficacious in patients with previously untreated FL , including high‐risk FLIPI groups. This trial was registered at www.clinicaltrials.gov ( NCT 00494780).