To assess the antitumor effect and safety of Fludara in patients 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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Patients received Fludarabine Phosphate orally for 5 consecutive days, followed by a 23-day observation period. Setting this as 1 treatment cycle, 6 cycles will be given.
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Kashiwa-shi, Chiba, Japan
Best overall response rate; Antitumor effect
Time frame: at screening and re-evaluation, at 4th week or at the time of discontinuation of treatment cycles 1, 3 and 6, and at 12th week after last observation of last treatment cycle
CR rate
Time frame: after last observation of last treatment cycle
Time to treatment failure
Time frame: after last observation of last treatment cycle
Overall survival
Time frame: after last observation of last treatment cycle
Adverse events collection
Time frame: after last observation of last treatment cycle
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Akashi-shi, Hyōgo, Japan
Unnamed facility
Kagoshima, Kagoshima-ken, Japan
Unnamed facility
Isehara-shi, Kanagawa, Japan
Unnamed facility
Kyoto, Kyoto, Japan
...and 7 more locations