This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
rituximab 375mg/m2 on Day 1 of every 35-day cycle
1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle
Complete Response Rate
The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.
Time frame: Up to 8 cycles (1 cycle is 35 days: 280 days)
Overall Response Rate
The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary.
Time frame: Up to 8 cycles (1 cycle is 35 days: 280 days)
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CHU d'Amiens
Amiens, France
Institut Bergonie
Bordeaux, France
CHU Hotel Dieu
Clermont-Ferrand, France
Centre Victor Hugo
Le Mans, France
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Nîmes, France
Hoptial Saint Louis
Paris Cedex 10, 75, France
Hopital Cochin
Paris, 75, Cedex 14, France
Klinikum Bamberg, fachbereich 3
Bamberg, Germany
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Berlin, Germany
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