Overview

Study of Recombinant Interleukin 21 in Combination With Rituxan for Non-Hodgkin's Lymphoma

Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ZymoGenetics
Treatments:
Rituximab
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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