This trial is active, not recruiting.

Condition lymphoma
Treatments chlorambucil, dexamethasone, fludarabine phosphate, mitoxantrone hydrochloride
Phase phase 3
Sponsor Lymphoma Trials Office
Start date May 2000
Trial size 500 participants
Trial identifier NCT00006250, BNLI-MCD/FMD, CDR0000068182, EU-20035


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Time to treatment failure
time frame:
Progression-free survival rate
time frame:
Overall survival rate
time frame:

Secondary Outcomes

Clinical remission rate
time frame:
Molecular remission rate
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).