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

ZymoGenetics

Status and phase

Completed

Phase 1

Conditions

Lymphoma, Non-Hodgkin

Treatments

Drug: recombinant human interleukin 21 and rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00347971

494E03

Details and patient eligibility

About

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).

Full 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 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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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