Status:
COMPLETED
Comparison Of Rituximab Versus Tositumomab and Iodine I 131 Tositumomab (BEXXAR® Therapeutic Regimen) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Comparison of rituximab versus Iodine I 131 Tositumomab Therapeutic Regimen (Tositumomab and Iodine I 131 Tositumomab or the Bexxar Therapeutic Regimen, formerly called Iodine-131 Anti-B1 Antibody) in...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically confirmed diagnosis of follicular lymphoma
- Recurrent lymphoma after one or two qualifying therapy regimen(s)
- Patients must not have progressed within 4 weeks of their last chemotherapy dose
- Rituximab may have been used once as a single agent, in one continuous course of 4-8 weekly infusions (10-week period), or in combination with chemotherapy in a single prior treatment
- Patients whose prior therapy includes rituximab must have had a 6 month or greater response duration following the rituximab-containing regimen.
- Performance status of at least 70% on the Karnofsky Scale and an anticipated survival of at least three months
- Adequate absolute neutrophil count and platelet count within 21 days of study entry without support of blood products/growth factors
- Adequate renal function and adequate hepatic within 21 days of study entry
- Measurable disease, with at least one lesion measuring \>/=2.0 cm x 2.0 cm by CT scan
- Human Anti Mouse Antigen negative
- Written informed consent prior to study entry
- Exclusion criteria:
- Histologic transformation to diffuse, large cell lymphoma.
- History of more than one course of Rituximab
- Disease limited to single lymph node or single group of nodes
- Involvement of 25% of the intratrabecular marrow by bone marrow biopsy specimen.
- Active infection requiring IV antibiotics at the time of study entry
- New York Heart Association Class III/IV heart disease
- Prior chemotherapy, biologic, radiation or steroid therapy for NHL within 8 weeks
- Any prior radioimmunotherapy
- Prior history of malignancy other than lymphoma (except for treated basal cell, squamous cell skin cancer, in situ cervical cancer, or other cancer that is disease-free for 5 years)
- Known HIV infection
- Hepatitis B positive
- Known central nervous system involvement
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00268983
Start Date
October 1 2004
End Date
June 1 2013
Last Update
January 9 2017
Active Locations (3)
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1
GSK Investigational Site
Walla Walla, Washington, United States, 99362
2
GSK Investigational Site
Pierre-Bénite, France, 69495
3
GSK Investigational Site
Manchester, Lancashire, United Kingdom