E2499 Randomized Phase III Trial of Rituximab (NSC #687451) and Autologous Stem Cell Transplantation for B Cell Diffuse Large Cell Lymphoma.

Protocol Number: RMBMT-147

Major Objectives

1. To compare disease free survival in patients with diffuse large cell lymphoma who have relapsed after achieving complete response (CR) or have failed to achieve initial CR undergoing stem cell transplant with or without post-transplant rituximab
2. To evaluate the effect of post-transplant rituximab on procedure related mortality
3. To describe the potential infectious complications of the addition of rituximab to autologous stem cell transplant.
4. To compare overall survival in the two arms.

Patient Selection

Inclusion Criteria:

1. Diagnosis of diffuse large cell lymphoma by the WHO classification
   
   • 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.
2. Pts with residual radiographic abnormalities after primary therapy are eligible if these abnormalities are also PET or Gallium positive.
   • Baseline CT scans obtained within 3 wks prior to registration are required.
   • PET scan only is insufficient.
3. Patients must not be newly diagnosed.
4. A maximum of 3 prior regimens (using chemo, radiation and immunotherapy) is permitted. Patients must not have progressive disease to the most recent salvager therapy.
5. Patients must be tested for hepatitis B surface antigen within 2 weeks of registration.
6. Patients with a second malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix are not eligible unless the tumor was treated with curative intent at least 2 years previously and the pt continues to be free of evidence of recurrence.
7. Pts must not have received prior radioimmunotherapy.
8. Required laboratory values (obtained ≤ 2 weeks prior to randomization)
   • ANC ≥ 1000
   • Plts ≥ 10,000
   • Serum Creatinine ≤ 2.0
9. Cardiac ejection fraction must be ≥ 40%
10. DLCO must be ≥ 60% predicted.
11. Pts must not have active infections requiring oral or intravenous antibiotics.
12. Pts must not have HIV infection due to risk of infection and excessive toxicity.
13. ECOG performance status 0 or 1.
14. Age ≥ 18 years or &le 70 years at the time of study entry.
15. Women must not be pregnant or breast feeding. Women of childbearing potential must have a blood test or urine test within 2 weeks prior to registration to rule out pregnancy.