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Orcharrd

This is a Phase II/III, parallel group, open label, active comparator, randomised (1:1), registration trial. Subjects must be refractory to, or have relapsed following, first-line treatment with rituximab in combination with an anthracycline containing regimen, and be eligible for ASCT. Subjects with the following disease responses will be deemed refractory: 1) progressive disease during first-line treatment, 2) stable disease after at least 3 cycles of first-line treatment, and 3) PR after at least 6 cycles of first-line treatment. For relapsed patients, or patients with PR, CD20 positive DLBCL must be re-confirmed during the interval between completion of first-line treatment and prior to trial entry. Subjects will be randomised to receive either rituximab or ofatumumab in combination with three cycles of salvage chemotherapy using DHAP-VIM-DHAP (DVD). A total of four doses of ofatumumab or rituximab will be dosed as follows: Day 1 and Day 8 of cycle 1, and Day 1 of cycle 2 and cycle 3. Disease assessments, including CT and PET scans, will be performed at screening. After the second cycle of salvage therapy a CT scan will be performed and subjects not achieving CR or PR will be considered treatment failures and will not receive any further protocol therapy. CT and PET scans will be performed after the third cycle of salvage therapy and, provided that there is continuing response, subjects will continue with treatment as per protocol. Recognised disease response criteria will be used (Cheson et al., 2007). According to local policy, during the second and/or third cycle of salvage therapy, stem cells will be mobilized with GCSF and harvested. Responding patients will receive high dose chemotherapy with BEAM followed by autologous stem cell transplantation. Success of engraftment will be assessed.