A Phase 2 interventional study of Fludarabine Phosphate (Fludara) and Rituximab in Lymphoma, Low-Grade, sponsored by Genzyme, a Sanofi Company. Completed at 8 sites in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2013-12-04.
Sponsored by Genzyme, a Sanofi Company · Phase 2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 41 is close to the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Fludarabine Phosphate (Fludara)
Drug: Rituximab
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)
Also known as: BAY86-4864
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)
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 study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Genzyme, a Sanofi Company