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

Stopped early · Phase 3

Conditions studied: Follicular Lymphoma

In brief

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.

Key facts

Study ID

NCT01662102

Run by

Spectrum Pharmaceuticals, Inc

People needed

1

Starts

2012-12-11

Expected to finish

2013-03-05

Last updated by the study team

2021-10-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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%.

Where it is running

• 21st Century Oncology — Sun City, Arizona, United States
• Northeast Georgia Cancer Care — Athens, Georgia, United States
• Illinois Cancer Specialists — Niles, Illinois, United States
• Park Nicollet Institute — Saint Louis Park, Minnesota, United States
• Charleston Area Medical Center — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.