Status:
COMPLETED
Study of Recombinant Interleukin 21 in Combination With Rituxan for Non-Hodgkin's Lymphoma
Lead Sponsor:
ZymoGenetics
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate whether recombinant IL-21 used in combination with rituximab is safe for patients with non-Hodgkin's lymphoma (NHL).
Detailed Description
This is a Phase 1 open-label dose-escalation study of rituximab + rIL-21 combination therapy, administered once weekly for 4 weeks following an initial treatment with one dose of rituximab alone to pa...
Eligibility Criteria
Inclusion
- Diagnosis of CD20+ B-cell NHL
- Disease measurable by computed tomography (CT) scan
- Has failed at least one prior systemic therapy for NHL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hepatic and renal function
- Adequate bone marrow function
Exclusion
- Presence of acute infection or other significant systemic illness
- White blood cell (WBC) count \> 50,000/mm3 in peripheral blood
- Central nervous system involvement by malignancy
- Previous allogenic transplant or autotransplant within 6 months of enrollment
- Other current malignancy or known history of cancer within 5 years
- Received systemic corticosteroids, chemotherapy, immunotherapy, biologic therapy, antibody therapy (e.g., rituximab), radiation therapy, and/or investigational agent(s) within 1 month of enrollment
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00347971
Start Date
June 1 2006
End Date
April 1 2008
Last Update
September 5 2008
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095