PHASE II MULTICENTER STUDY OF IODINE-131 ANTI-B1 ANTIBODY CONSOLIDATION FOR PATIENTS WITH DIFFUSE LARGE B-CELL NON-HODGKIN'S LYMPHOMA FOLLOWING FIRST-LINE CHOP
Inclusion Criteria:
- Male or female subjects age 18 to 80 years, inclusive, with any International
Prognostic Index score; treated with 6 or more cycles of first-line CHOP chemotherapy
and achieved a PR, CRu, or CR
- de novo diffuse large B cell NHL according to the REAL classification; Ann Arbor
stage III, stage IV, or bulky stage II disease (any mass ≥10 cm in diameter)
- less than an average of 25% of the intratrabecular marrow space involved by NHL in
bilateral bone marrow biopsy specimens or <10% involvement with NHL from unilateral
bone marrow biopsy; tumor tissue expressing the CD20 antigen
- ≥60% performance status on the Karnofsky Performance Scale and an anticipated
survival of at least 3 months
- absolute neutrophil count (ANC) ≥1500 cells/mm3 and platelet count ≥100,000/mm3
- adequate renal function (serum creatinine <1.5 × upper limit of normal [ULN]) and
hepatic function (total bilirubin ≤2.0 × ULN and aspartate aminotransferase <5 × ULN)
Exclusion Criteria:
- Prior radiation, prior biological therapy, or prior chemotherapy other than
first-line CHOP
- active bilateral obstructive hydronephrosis
- New York Heart Association class III or IV heart disease or other serious illness
- prior malignancy other than lymphoma (except for adequately treated skin cancer, in
situ cervical cancer, or other cancer for which they had been disease-free for >5
years)
- human immunodeficiency virus infection
- HAMA positive
- brain or leptomeningeal metastases at any time since diagnosis
- active infection requiring intravenous anti-infectives
- pregnant or breastfeeding