Comparing Two Schedules of Rituximab Maintenance in Rituximab-Responding Patients With Untreated, Chemotherapy Resistant or Relapsed Follicular Lymphoma: A Randomized Phase III Trial
- Compare the efficacy of induction therapy with rituximab followed by short- vs
long-term maintenance therapy with rituximab, in terms of event-free survival, in
patients with follicular non-Hodgkin's lymphoma.
- Compare the safety of these regimens in these patients.
- Compare the pharmaeconomical aspects of these regimens in these patients.
- Compare the evolution of immunologic competence in patients treated with these
OUTLINE: This is a randomized, multicenter study.
- Induction therapy: Patients receive rituximab IV weekly in weeks 1-4 and undergo
restaging between weeks 11-13. Patients with stable disease or progressive disease are
taken off study. Patients achieving partial or complete response are stratified
according to prior treatment status (untreated* vs treated with or without anti-CD20
therapy), presence of bulky disease** at study entry (yes vs no), and participating
center. Patients are then randomized to 1 of 2 maintenance treatment arms.
NOTE: *Patients treated with radiotherapy only are considered as therapy-naïve.
NOTE: **Defined as a mass or lymph node conglomerate ≥ 5 cm diameter.
- Maintenance therapy: Patients start maintenance therapy within 7 days of randomization.
- Arm I: Patients receive rituximab IV every 2 months for 4 treatments.
- Arm II: Patients receive rituximab IV every 2 months for up to 5 years in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease
progression or relapse and then annually for up to 10 years after randomization.
PROJECTED ACCRUAL: A total of 270 patients will be accrued for this study within 3 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
at 10 years
Christian Taverna, MD