An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients With Advanced Stage, Asymptomatic, Non-Bulky Follicular Lymphoma
- Compare time to initiation of systemic chemotherapy or radiotherapy in patients with
newly diagnosed, previously untreated, asymptomatic stage II-IV non-bulky follicular
non-Hodgkin's lymphoma treated with rituximab vs observation only.
- Compare the frequency of clinical spontaneous remission in patients treated with these
- Compare overall and cause-specific survival of patients treated with these regimens.
- Determine the effect of rituximab on complete and partial response in patients treated
with subsequent systemic chemotherapy.
- Compare quality of life, in terms of functional well-being and anxiety and depression,
of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, disease grade (1 vs 2 vs 3a), disease stage (II vs III vs IV), and
age. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo observation only until disease progression.
- Arm II: Patients receive induction rituximab IV on day 1. Treatment repeats weekly for
up to 4 weeks.
- Arm III: Patients receive induction rituximab as in arm II. Patients then receive
maintenance rituximab IV once on day 1 of weeks 12, 20, 28, 36, 44, 52, 60, 68, 76, 84,
92, and 100.
In all arms, treatment continues in the absence of unacceptable toxicity or disease
progression requiring systemic chemotherapy* or radiotherapy.
NOTE: *Rituximab administration in arm I is considered initiation of systemic chemotherapy
Quality of life is assessed at baseline (before and after randomization), every 2 months for
2 years, and then every 6 months for 2 years.
Patients are followed every 2 months for 2 years and then every 3 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 600 patients (200 per treatment arm) will be accrued for this
study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Time until initiation of therapy (chemotherapy or radiotherapy)
Mount Vernon Cancer Centre at Mount Vernon Hospital