Conditions: Lymphoma, Follicular
Keywords: CHOP (cyclophosphamide,doxorubicin,vincristine,prednisolone) ofatumumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 59
Healthy volunteers: no

Brief summary:
To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)

Detailed description:

Arms:
arm 1: Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg arm 2: Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg

Interventions: intervention 1: Ofatumumab intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Vincristine intervention 5: Prednisolone, Prednisone or equivalent
Intervention descriptions: intervention 1: ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given intervention 2: Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start intervention 3: Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start intervention 4: Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start intervention 5: 100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start

Protocol document: