Status:
TERMINATED
Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. Elig...
Eligibility Criteria
Inclusion
- Male or female subjects 18 years or older
- Histologically proven diagnosis of follicular non-Hodgkin's lymphoma grades 1or 2 according to the World Health Organization classification
- Subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject's medical record
- Documented relapse or progression following last antineoplastic treatment
- At least 1 measurable tumor mass (≥1.5 cm x ≥1.0 cm)
Exclusion
- Subjects with histological or clinical transformation to an aggressive lymphoma
- prior treatment with VELCADE or fludarabine.
- antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
- nitrosoureas within 6 weeks before randomization
- radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
- major surgery within 3 weeks before randomization
- chronic use of corticosteroids, such as dexamethasone
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00850499
Start Date
September 1 2009
End Date
October 1 2011
Last Update
December 12 2012
Active Locations (43)
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1
CHU d'Amiens
Amiens, France, 80054
2
Institut Bergonie
Bordeaux, France, 33076
3
CHU Hotel Dieu
Clermont-Ferrand, France, 63000
4
Centre Victor Hugo
Le Mans, France, 72000