Conditions: Lymphoma, Follicular
Keywords: ofatumumab rituximab NHL CD20 refractory
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 116
Healthy volunteers: no

Brief summary:
A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy

Detailed description:
Patients in the study will be randomized into two dose groups. Patients in each dose group will receive one infusion of 300 mg of HuMax-CD20 followed by 7 weekly infusions of either 500 or 1000 mg of HuMax-CD20. Disease status will be assessed every 3 months until month 24.

Arms:

Interventions: intervention 1: Ofatumumab intervention 2: Ofatumumab
Intervention descriptions: intervention 1: Eight weekly infusions of ofatumumab. The first infusion of 300mg ofatumunab intervention 2: followed by 7 weekly infusions of 1000mg ofatumumab

Protocol document: