Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma
- Compare the overall survival rate, progression free survival rate, clinical and
molecular remission rates, and time to treatment failure in patients with newly
diagnosed stage III or IV follicular non-Hodgkin's lymphoma treated with chlorambucil,
mitoxantrone, and dexamethasone versus fludarabine, mitoxantrone, and dexamethasone.
- Compare the efficacy and tolerability of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
International Prognostic Index score [low risk (score 1) vs intermediate low risk (score 2)
vs intermediate high risk (score 3) vs high risk (score 4 or 5)]. Patients are randomized to
one of two treatment arms.
- Arm I: Patients receive mitoxantrone IV on day 1, oral chlorambucil on days 1-10, and
oral dexamethasone on days 1-5.
- Arm II: Patients receive mitoxantrone and dexamethasone as in arm I and fludarabine IV
on days 1-3.
Treatment continues every 4 weeks for 4-8 courses.
Patients are followed at 3, 6, and 12 months, every 6 months for 1 year, and then annually
thereafter until clinical relapse.
PROJECTED ACCRUAL: A total of 500 patients (250 per arm) will be accrued for this study
within 4 years.
Allocation: Randomized, Primary Purpose: Treatment
Time to treatment failure
Andy Haynes, MD
Nottingham City Hospital
United States: Federal Government