Conditions: Non-Hodgkin Lymphoma
Keywords: Bendamustine hydrochloride CEP-18083 Treanda® Non-Hodgkin Lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 102
Healthy volunteers: no

Brief summary:
The primary objective of the study is to determine the overall response rate (ORR), which includes complete response (CR) and partial response (PR), to bendamustine treatment in participants with indolent non-Hodgkin lymphoma (NHL) that has progressed after rituximab or a rituximab-containing therapy.

Detailed description:
This is a multicenter, nonrandomized, open-label, single-agent clinical study conducted in China, and is designed to investigate the use of bendamustine in the treatment of Chinese participants with relapsed, rituximab-refractory indolent NHL. The study consists of a screening period of up to 4 weeks, a treatment period of approximately 24 weeks (up to eight 21-day cycles), and a long-term follow-up period for up to 2 years after the last dose of study drug. Participants are expected to participate in this study for approximately 2.5 years.

Arms:
arm 1: Participants will receive bendamustine hydrochloride administered at 120 milligrams (mg)/square meter (m\^2) intravenously (IV) as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.

Interventions: intervention 1: Bendamustine hydrochloride
Intervention descriptions: intervention 1: Bendamustine will be be administered per dose and schedule specified in the arm description.

Protocol document: