Phase 1, Open-Label, Dose-Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 (rIL-21) Administered in Combination With Rituxan (Rituximab) in Subjects With B-Cell Non Hodgkin's Lymphoma
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 patients with B-cell non-Hodgkin's lymphoma (NHL) who have failed
prior therapy(ies). A standard dose of rituximab will be used. Increasing doses of rIL-21
will be studied sequentially in different groups of patients, starting with 30 μg/kg.
Before starting treatment with rituximab + rIL-21, patients will be treated with one dose of
rituximab alone to look for rituximab infusion-related symptoms (such as fever, chills, and
rigors). Patients who have severe infusion-related side effects after the first dose of
rituximab will not go on to receive IL-21. Those who do not have unacceptable
rituximab-related side effects will receive intravenous rIL-21 at least 60 minutes after
completing the rituximab infusion at the rest of the weekly dosing visits. Patients will be
evaluated for safety over the course of the study. Disease evaluation (tumor restaging) will
be performed 2 weeks following completion of the first 4-week treatment cycle. Patients with
stable disease or better at this evaluation may go on to receive a second 4-week treatment
cycle of rituximab + rIL-21. Patients may be in the study for 2 to 4 months.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence and severity of adverse events through 1 month after completing treatment
During treatment and through 1 month after completing treatment
Yes
Muriel Siadak, PA-C
Study Director
ZymoGenetics
United States: Food and Drug Administration
494E03
NCT00347971
June 2006
April 2008
Name | Location |
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University of California, Los Angeles | Los Angeles, California |