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Brief Title: Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL
Official Title: A Multicenter Study to Assess the Antitumor Effect and Safety of Fludarabine Phosphate Tablet (SH T 586) in Combination With Rituximab Administered in 6 Treatment Cycles (1 Treatment Cycle: Rituximab 375 mg/m2 iv on Day 1 Along With 5-Consecutive Day Oral Dosing of SH T 586 40 mg/m2/Day From Day 1 to Day 5, Followed by an Observation Period of 23 Days) in Patients With Indolent Lymphoma
Study ID: NCT00311129
Brief Summary: The purpose of this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient with indolent lymphoma.
Detailed Description: As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Nagoya-shi, Aichi, Japan
, Nagoya-shi, Aichi, Japan
, Kashiwa-shi, Chiba, Japan
, Isehara-shi, Kanagawa, Japan
, Kyoto-shi, Kyoto, Japan
, Sendai-shi, Miyagi, Japan
, Hamamatsu-shi, Shizuoka, Japan
, Chuo-ku, Tokyo, Japan
Name: Medical Monitor
Affiliation: Genzyme, a Sanofi Company
Role: STUDY_DIRECTOR