Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Bortezomib; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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