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

An Open-Label, Multicenter, Randomized Study in Previously Untreated Follicular Lymphoma Patients to Evaluate the Efficacy of Consolidation With Zevalin® Versus Maintenance Treatment With Rituximab After Initial Therapeutic Response to Rituximab Plus Chemotherapy

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.

This is an open-label, multicenter and randomized study. Participants registered after response induction (PR/CR) to R-chemotherapy. Participants achieving either a partial response (PR) or complete response (CR) following R-chemotherapy eligible for randomization to either consolidation with 90Y-ibritumumab tiuxetan followed by observation for 24 months, or rituximab maintenance for 24 months. After the observation/maintenance period, patients follow up for 5 years.

This study was terminated early for business reasons. (Maximum duration of study was up to approximately 2.7 months).

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%.