SWOG-9704 A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+ B Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant) for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups

Date de début de l'étude : 1 juillet 1997

DISEASE CHARACTERISTICS: Histologically proven intermediate- or high-grade non-Hodgkin's lymphoma Ann Arbor classification of "bulky" stage II, III, or IV Must be classified as high-intermediate or high-risk according to International Age Adjusted Index Bidimensionally measurable disease No lymphoblastic, transformed, or mantle cell lymphomas No CNS involvement by lymphoma CD20 status confirmed by immunocytochemistry or flow cytometry Must have either bilateral or unilateral bone marrow aspiration and biopsy ≥ 42 days before first course of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy (or CHOP plus rituximab [CHOP-R] for CD20+ disease) OR within 42 days prior to registration if CHOP/CHOP-R therapy has not begun Must have bilateral bone marrow aspiration and biopsy within 28 days of randomization Bone marrow involvement with lymphoma is allowed, provided there is an improvement of at least 50% if used as an evaluable site of disease No prior lymphoma, Hodgkin's lymphoma, myelodysplastic syndromes, or leukemia NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) No nonlymphoma-related hepatic dysfunction Renal: Creatinine no greater than 2 times ULN Creatinine clearance at least 60 mL/min No nonlymphoma-related renal dysfunction No history of grade 3 hemorrhagic cystitis due to cyclophosphamide Cardiovascular: No coronary artery disease, cardiomyopathy, congestive heart failure, or dysrhythmia requiring therapy MUGA scan or 2-D echocardiogram required if patient's history is questionable Ejection fraction normal Pulmonary: DLCO or FEV_1 at least 60% of predicted Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No allergy to etoposide No active bacterial, fungal, or viral infection PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy for lymphoma except if included in a single course of CHOP/CHOP-R Chemotherapy: No prior chemotherapy for lymphoma except for a single course of CHOP/CHOP-R* NOTE: *Prednisone or other corticosteroids not considered prior chemotherapy Endocrine therapy: See Chemotherapy Prior corticosteroids allowed Radiotherapy: No prior radiotherapy for lymphoma No prior thoracic radiotherapy or radiotherapy greater than 2,000 cGy to any other site Surgery: Not specified