Rituximab Plus Lenalidomide or Rituximab Monotherapy for Untreated Patients With Follicular Lymphoma in Need of Therapy. A Randomized, Open-Label, Multicenter Phase II Trial.
- To determine the activity of rituximab in combination with lenalidomide versus
rituximab alone in patients with previously untreated follicular lymphoma in need of
- To determine the safety of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to grade of disease
(grades 1 or 2 vs 3a), presence of bulky disease (defined as masses ≥ 6 cm) (yes vs no),
Follicular Lymphoma International Prognostic Index score (1 or 2 vs ≥ 3), and participating
centers. Patients are randomized to 1 of 2 treatment arms.
- Arm A: Patients receive rituximab IV on day 1 in weeks 1, 2, 3, 4 and weeks 12, 13, 14,
15 in the absence of disease progression or unacceptable toxicity.
- Arm B: Patients receive rituximab IV as in arm A. Patients also receive oral
lenalidomide once daily, starting 14 days before first rituximab administration and
last until 14 days after the last rituximab administration, in the absence of disease
progression or unacceptable toxicity.
All patients undergo restaging at week 10. Patients who show less than a minimal response
(i.e., reduction of more than 25% in sum of product of diameters [SPD]) are off study
treatment and transferred to the follow-up phase. Patients undergo a second restaging in
Some patients may undergo biopsies and blood and bone marrow sample collection periodically
for biomarker studies.
After completion of study treatment, patients are followed up periodically for 20 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response at week 23
at week 23
Emanuele Zucca, MD
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni