Lymphoma
Conditions
Keywords
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
Brief summary
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.
Detailed 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.
Interventions
DRUGchlorambucil
DRUGdexamethasone
DRUGfludarabine phosphate
DRUGmitoxantrone hydrochloride
Sponsors
Lymphoma Trials Office
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to treatment failure | — |
| Progression-free survival rate | — |
| Overall survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical remission rate | — |
| Molecular remission rate | — |
Countries
United Kingdom
Outcome results
None listed