Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Swiss Cancer Institute
OBJECTIVES: Primary * 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. Secondary * 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 regimens. 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted