A Multi-Center, Randomized, Phase III Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma
- A histologically confirmed diagnosis of follicular lymphoma, Grade I, II, or III
(WHO/REAL Classification) (follicular, small cleaved; follicular, mixed small-cleaved
and large-cell; or follicular large-cell lymphoma in the International Working
- Recurrent lymphoma after one or two qualifying therapy regimen(s).
- A performance status of at least 70% on the Karnofsky Scale.
- An absolute neutrophil count > 1500 cells/mm3 and a platelet count > 100,000
- Adequate renal function and adequate hepatic function.
- Bi-dimensionally measurable disease with at least one lesion measuring > or equal to
2.0 x 2.0 cm (i.e., > 4.0 cm2) by CT scan.
- HAMA negative.
- At least 18 years of age.
- Give written informed consent by signing an IRB/ethics committee approved informed
consent form prior to study entry.
- Histological transformation to diffuse,large cell lymphoma
- More than 1 course of rituximab
- Disease better treated with limited field therapy
- Involvement of >25% of the intratrabecular marrow
- Active infection
- Significant cardiac disease
- Prior ChemoRx, biological therapy, radiation Rx, or high dose systemic steroid
therapy within 8 weeks
- Prior radioimmunotherapy
- History of another malignancy
- HBsAg positivity
- CNS involvement with lymphoma
- Pregnant or nursing
- Ascites by physical exam
- Previous use of non-human monoclonal antibody therapy, known hypersensitive to murine
- Radiotherapy to >25% of the blood forming marrow
- Prior stem cell transplant
- Failed stem cell harvest