Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive B-Cell Diffuse Large Cell Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies, such as rituximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether stem cell transplantation is more effective with or without rituximab in treating relapsed or progressive B-cell diffuse large cell lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of stem cell transplantation with or without rituximab in treating patients who have relapsed or progressive B-cell diffuse large cell lymphoma.

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

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborators: Cancer and Leukemia Group B; National Cancer Institute (NCI)
• Treatments: Carmustine; Cyclophosphamide; Etoposide; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of diffuse large cell lymphoma and meeting the following criteria:

• B-cell type with expression of CD20 either at diagnosis or at relapse

• Relapse after having achieved an initial complete remission (CR) or failure to achieve initial CR (residual radiographic abnormalities after primary therapy allowed if these abnormalities are also positive by positron emission tomography or MRI [gallium])

• No newly diagnosed disease

• No progressive or stable disease to most recent salvage therapy

PATIENT CHARACTERISTICS:

Age

• 18 to 70

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 2.0 mg/dL

• AST or ALT < 3 times upper limit of normal

Renal

• Creatinine ≤ 2.0 mg/dL OR

• Creatinine clearance ≥ 40 mL/min

Cardiovascular

• Cardiac ejection fraction ≥ 40%

Pulmonary

• DLCO ≥ 60% of predicted

Other

• No other malignancy within the past 2 years except basal cell skin cancer or carcinoma in situ of the cervix

• No active infection requiring oral or IV antibiotics

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Chemotherapy

• No more than 3 prior immunotherapy regimens

Chemotherapy

• No more than 3 prior chemotherapy regimens

• Addition of radiation or a monoclonal antibody to chemotherapy is considered one treatment regimen if the addition was part of the initial treatment plan

• Addition of these therapies due to lack of response or poor response would be considered an additional treatment regimen whether given in front-line or salvage setting

Endocrine therapy

• Not specified

Radiotherapy

• See Chemotherapy

• No more than 3 prior radiotherapy regimens

• No prior radioimmunotherapy

Surgery

• Not specified