Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma
18 Years
70 Years
Both
Lymphoma
Trial Information
Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven newly diagnosed stage III or IV follicular non-Hodgkin's
lymphoma
- REAL classification grade I, II, or III
- Treatment necessity indicated by presence of the following:
- B symptoms
- Bone marrow failure
- Bulky or progressive disease
- Compression syndromes
- No CNS involvement
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- No autoimmune hemolytic anemia or active hemolysis
- Direct Coombs' negative
Hepatic:
- Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)*
- Bilirubin no greater than 2.5 times ULN* NOTE: *Unless attributable to lymphoma
Renal:
- Creatinine no greater than 2.5 times ULN (unless attributable to lymphoma)
Cardiovascular:
- No severe cardiac failure
- Ejection fraction at least 45%
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for at least 6 months
after study
- HIV negative
- No prior malignancy except carcinoma in situ of the cervix or squamous cell skin
cancer
- No other serious medical disease that would limit lifespan or ability to tolerate
chemotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent systemic corticosteroids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No prior therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Time to treatment failure
Safety Issue:
No
Principal Investigator
Andy Haynes, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Nottingham City Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000068182
NCT ID:
NCT00006250
Start Date:
May 2000
Completion Date:
Related Keywords:
- Lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
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