Lymphoma Clinical Trial
Official title:
Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. It is not yet known which combination chemotherapy regimen is
more effective for non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different
combination chemotherapy regimens in treating patients who have stage III or stage IV
non-Hodgkin's lymphoma.
OBJECTIVES:
- 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
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