Conditions: Non-Hodgkin's Lymphoma (NHL)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

Brief summary:
The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).

Detailed description:

Arms:
arm 1: There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m\^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.

Interventions: intervention 1: Bendamustine hydrochloride intervention 2: Ofatumumab
Intervention descriptions: intervention 1: Bendamustine will be administered at 90 mg/m\^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle. intervention 2: Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.

Protocol document: