Phase III Stidy of Zevalin And BEAM Compared With BEAM Alone Prior to Autologous Hematopoietic Steem Cell Transpl. in Pts Relapse of Non-Hodgkins Lymphoma
1. Patients with CD20 positive aggressive non-Hodgkin's lymphoma, either diffuse large
B-cell or transformed follicular lymphoma as confirmed by a pathological biopsy
2. Patients who are candidates for stem-cell transplantation due to refractory disease
to first line chemotherapy or relapsing disease and comply with standard transplant
3. Patients must have chemo-sensitive disease achieving at least partial response to
4. Patients were given up to 2 lines of therapy, initial treatment and one salvage
treatment. Local radiation therapy for consolidation is not considered a line of
5. Age less than physiologic 65 years.
6. Patients with an adequate autologous stem cell collection for transplantation (>2.5 x
106 CD34+ cells/kg). Backup collection is preferable but not obligatory.
7. Patients must sign written informed consent.
8. Adequate birth control in fertile patients.
9. All prior chemotherapy completed at least three weeks before study treatment
1. Chemo-refractory disease or more than 2 prior therapies
2. Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
3. Creatinine > 2.0 mg/dl
4. ECOG-Performance status < 2
5. Uncontrolled infection
6. Pregnancy or lactation
7. Abnormal lung diffusion capacity (DLCO < 40% predicted)
8. Severe cardiovascular disease
9. Chemo-refractory disease as determined by less than partial response to salvage
10. active CNS disease involvement
11. Pleural effusion or ascites > 1 liter
12. Known hypersensitivity to rituximab
13. Psychiatric conditions/disease that impair the ability to give informed consent or to