Status:
UNKNOWN
A Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Non-Hodgkin's Lymphoma
Lead Sponsor:
Corixa Corporation
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States and Europe. Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will rece...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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 Formulation).
- 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 cells/mm3.
- 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.
- Exclusion Criteria
- 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 proteins
- Hydronephrosis
- Radiotherapy to \>25% of the blood forming marrow
- Prior stem cell transplant
- Failed stem cell harvest
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT00078598
Start Date
April 1 2004
Last Update
November 9 2005
Active Locations (5)
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1
Northside Hospital
Atlanta, Georgia, United States, 30342
2
Medical Oncology/Hematology Associates
Dayton, Ohio, United States, 45409
3
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
4
St Mary Medical Center/Regional Cancer Center
Walla Walla, Washington, United States, 99362