Zevalin-beam for Aggressive Lymphoma

Inclusion criteria

• Patients with CD20 positive diffuse large B-cell lymphoma as confirmed by a pathological biopsy report.
• Patients who are candidates for autologous stem-cell transplantation due to primary refractory or first relapse of disease.
• Patients must have chemo-sensitive disease achieving at least partial response (Cheson 2007 criteria) to last chemotherapy.
• Age ≥ 18 years and age ≤ 70
• Patients with adequate autologous stem cell collection for transplantation (target ≥ 2.5 x 106 CD34+ cells/kg).
• Patients must sign written informed consent.
• Adequate birth control in fertile patients.
• All prior chemotherapy completed at least three weeks before study treatment.
• Marrow involvement less than 25% at transplantation, no limitation on blood counts (low platelet count allowed).
• Negative HIV antibody.

Exclusion criteria

• 1. Chemo-refractory disease as determined by less than partial response (Cheson 2007 Criteria) to last chemotherapy.
• Two or more relapses after initial response to induction chemotherapy.
• High-grade transformation from earlier diagnosis of low-grade lymphoma. Patients with "De Novo" Transformed DLBCL, defined as DLBCL only on lymph node biopsy and a discordant marrow with para-trabecular small cells at first diagnosis of lymphoma, are eligible if adherent all other selection criteria.
• Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit.
• Creatinine > 2.0 mg/dl.
• ECOG Performance status > 2.
• Uncontrolled infection.
• Pregnancy or lactation.
• Abnormal lung diffusion capacity (DLCO < 40% predicted).
• Severe cardiovascular disease; New York Heart Association (NYHA) Functional Classification ≥2.
• Active CNS disease involvement.
• Presence of any other malignancy or history of prior malignancy within 5 years of study entry. Within 5 years, patients treated for Stage I or II cancers are eligible provided they have a life expectancy > 5 years in relation to this prior malignance. The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer.
• Pleural effusion or ascites > 1 liter.
• Known hypersensitivity to rituximab.
• Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate.
• Prior radioimmunotherapy.
• Prior autologous or allogeneic HSCT.
• Active evidence of Hepatitis B or C infection; Hepatitis B surface antigen positive.
• Patients who have had prior radiation to the lung will be excluded from the study, although mediastinal irradiation will be permitted if minimal lung is in the treatment volume.
• Patients who have received >500cGy radiation to the kidneys will be excluded from the study.