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Brief Title: A Study of Bendamustine in the Treatment of Chinese Participants With Indolent Non-Hodgkin Lymphoma Refractory to Rituximab Treatment
Official Title: An Open-Label Study to Evaluate Bendamustine Hydrochloride in the Treatment of Chinese Patients With Indolent Non-Hodgkin Lymphoma (NHL) Refractory to Rituximab Treatment
Study ID: NCT01596621
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Teva Investigational Site 001, Beijing, , China
Teva Investigational Site 026, Beijing, , China
Teva Investigational Site 022, Beijing, , China
Teva Investigational Site 004, Beijing, , China
Teva Investigational Site 003, Beijing, , China
Teva Investigational Site 002, Beijing, , China
Teva Investigational Site 023, Beijing, , China
Teva Investigational Site 016, Beijing, , China
Teva Investigational Site 021, Beijing, , China
Teva Investigational Site 015, Changchun, , China
Teva Investigational Site 010, Chengdu, , China
Teva Investigational Site 008, Guangzhou, , China
Teva Investigational Site 007, Guangzhou, , China
Teva Investigational Site 011, Hangzhou, , China
Teva Investigational Site 019, Harbin, , China
Teva Investigational Site 025, Hefei, , China
Teva Investigational Site 024, Lanzhou, , China
Teva Investigational Site 012, Nanjing, , China
Teva Investigational Site 013, Nanjing, , China
Teva Investigational Site 006, Shanghai, , China
Teva Investigational Site 005, Shanghai, , China
Teva Investigational Site 009, Shenyang, , China
Teva Investigational Site 027, Shenyang, , China
Teva Investigational Site 020, Suzhou, , China
Teva Investigational Site 014, Tianjin, , China
Teva Investigational Site 018, Xi'an, , China
Teva Investigational Site 017, Zhengzhou, , China
Name: Teva Medical Expert, MD
Affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
Role: STUDY_DIRECTOR