Status:
COMPLETED
Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will further characterize the activity of Tositumomab and Iodine I 131-Tositumomab in patients with relapsed indolent non-Hodgkin's Lymphoma who have progressed following treatment with rit...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients must have evidence of persistent or progressive follicular grade, 1, 2 or 3 or marginal zone B-cell non-Hodgkin's lymphoma.
- Must have received at least two prior courses of systemic treatment including at least one treatment of rituximab (lymphoma must not have progressed during their most recent systemic chemotherapy treatment).
- Must have evidence that their lymphoma expresses CD20 antigen and have adequate renal and hepatic function.
- Exclusion criteria:
- Received chemotherapy, radiation therapy, immunosuppressants or cytokine treatment within 4 weeks prior to study entry.
- Have active obstructive hydronephrosis.
- Had prior autologous hematopoietic stem cell transplant or any allogenic stem cell transplant.
- Have active infection requiring IV antibiotics.
- Have brain or leptomeningeal metastasis.
- Had previous allergic reaction to iodine, previously received radioimmunotherapy or are currently receiving approved or experimental anti-cancer drugs.
- Patients who are pregnant or breast feeding, have known HIV infection, or are Human anti-murine antibody (HAMA) positive.
- Other criteria will be evaluated at the screening visit.
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00240565
Start Date
April 1 2004
End Date
September 1 2011
Last Update
August 13 2012
Active Locations (11)
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1
GSK Investigational Site
Calgary, Alberta, Canada, T2N 4N2
2
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
3
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
4
GSK Investigational Site
Hamilton, Ontario, Canada, L8V 5C2