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
This is an open-label, multicenter and randomized study. Patients will be registered after
response induction (PR/CR) to R-chemotherapy. Patients achieving either a PR or CR following
R-chemotherapy will be 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 will be followed for 5 years.
This study is designed to be similar to the ZAR2007 study (EUDRACT No. 2007-006601-25)
carried out by PETHEMA in Spain. It is expected that Spanish centers will contribute up to
230 patients; centers in the US and elsewhere will contribute the remaining 254 patients.
The same randomization procedure will be used in both studies. The total sample size for the
combined studies will be 484 randomized patients. Assuming that PFS will follow an
exponential distribution with a constant hazard rate, with a 36 months uniform accrual
period and an additional follow-up time of 60 months after the last patient is randomized,
242 patients per arm (484 total) will be necessary to observe 131 PFS events in the combined
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS), defined as time from randomization to progression, relapse and/or death from any cause, or need for a new treatment regardless of reason.
Fernando Cabanillas, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|Charleston Area Medical Center||Charleston, West Virginia 25304|
|Northeast Georgia Cancer Care||Athens, Georgia 30607|
|Illinois Cancer Specialists||Niles, Illinois 60714|
|21st Century Oncology||Scottsdale, Arizona 85251|