Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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 regimen of combination chemotherapy is most effective for non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy and comparing how well they work in treating patients with aggressive non-Hodgkin's lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lymphoma Trials Office
• Treatments: Bleomycin; Cyclophosphamide; Doxorubicin; Etoposide; Liposomal doxorubicin; Mitoxantrone; Prednisolone; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven previously untreated bulky stage IA or stage IB-IV aggressive non-Hodgkin's lymphoma of 1 of the following types:

• Working formulation:

• Follicular large cell

• Diffuse mixed cell

• Diffuse large cell

• Diffuse immunoblastic OR

• REAL classification:

• Diffuse large B-cell

• Peripheral T-cell

• Measurable or evaluable disease

• Good prognosis defined as no more than one of the following:

• Stage III/IV disease

• LDH greater than upper limit of normal

• ECOG/WHO 2-4

• No lymphoblastic or Burkitt's lymphoma

• No CNS involvement

PATIENT CHARACTERISTICS:

Age:

• 18 to 59

Performance status:

• See Disease Characteristics

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 10 g/dL

• Neutrophil count at least 2,000/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin, AST, and ALT no greater than 1.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.7 mg/dL

Cardiovascular:

• Ejection fraction at least 50% unless dysfunction attributable to lymphoma

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other concurrent serious uncontrolled medical conditions

• No other prior malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to more than 35% of hematopoietic sites

• Concurrent consolidation radiotherapy allowed

Surgery:

• Not specified