Conditions: Lymphoma, Follicular
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 95
Healthy volunteers: no

Brief summary:
The primary objective of the study is to assess the pharmacokinetic (PK) similarity of Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients with low tumor burden follicular lymphoma (LTBFL).

The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of anti-drug antibodies (ADAs).

Detailed description:

Arms:
arm 1: BI695500, once a week for 4 weeks (4 administrations in total) arm 2: MabThera, once a week for 4 weeks (4 administration in total)

Interventions: intervention 1: BI 695500 intervention 2: MabThera
Intervention descriptions: intervention 1: BI695500, once a week for 4 weeks (4 administrations in total) intervention 2: MabThera, once a week for 4 weeks (4 administrations in total)

Protocol document: