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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Injection of rituximab on Day 1 along with 5-consecutive day oral dosing of fludarabine phosphate from Day 1 to Day 5, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
Injection of rituximab on Day 1, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Kashiwa-shi, Chiba, Japan
Unnamed facility
Isehara-shi, Kanagawa, Japan
Overall response rate
Time frame: The best response until the end of 6th treatment cycle
CR rate
Time frame: CR or CRu until the end of 6th treatment cycles
Progression free survival
Time frame: Progression or death which comes earlier, observed until 12 weeks after the completion of the treatment in the last patient
Overall survival
Time frame: Death, observed until 12 weeks after the completion of the treatment in the last patient
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Kyoto, Kyoto, Japan
Unnamed facility
Sendai, Miyagi, Japan
Unnamed facility
Hamamatsu, Shizuoka, Japan
Unnamed facility
Chuo-ku, Tokyo, Japan