Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta)

• Status: Terminated
• Trial end date: 2013-03-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of consolidation treatment Zevalin® versus maintenance treatment with Rituxan® on progression-free survival (PFS) following response induction with chemotherapy plus rituximab in previously untreated participants with follicular lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc
• Treatments: Antibodies, Monoclonal; Rituximab

Criteria

Inclusion Criteria:

• 18 to 75 years of age.

• Previously untreated with histologically confirmed grade 1, 2 or 3a cluster of differentiation-20 (CD20)-positive follicular lymphoma, with any of the GELF (Groupe d'Etude de Lymphomes Folliculaires) treatment criteria prior to induction.

• Achieved a response to induction treatment with either rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (6 cycles of R-CHOP21 or R-CHOP14), rituximab-cyclophosphamide, vincristine and prednisone (R-CVP) (6 cycles), or rituximab-bendamustine (R-B) (4 to 6 cycles).

• Must have completed all doses of the induction treatment, except for the modifications allowed in the protocol.

Exclusion Criteria:

• Transformation to high grade lymphoma (secondary to "low grade" follicular lymphoma [FL]).

• Grade 3b follicular lymphoma.

• Primary follicular lymphoma of the skin or gastrointestinal tract.

• Previous treatment of follicular lymphoma.

• Altered renal and hepatic function.

• Known human immunodeficiency virus (HIV) infection and/or active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection

• Serious co-morbid conditions (for example, ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).

• Life expectancy < 6.

• Must have:

• Platelet count ≥ 100x10^9/L.

• Bone marrow infiltration <25%.