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

Sponsor

ZymoGenetics (Industry)

Overall Status

Completed

CT.gov ID

NCT00347971

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin	Drug: recombinant human interleukin 21 and rituximab	Phase 1

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Outcome Measures

Primary Outcome Measures

Incidence and severity of adverse events through 1 month after completing treatment [During treatment and through 1 month after completing treatment]
Incidence and grade of clinical laboratory abnormalities through 1 month after treatment [During treatment and through 1 month after completing treatment]

Secondary Outcome Measures

Disease response by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas 2 weeks after completion of the first treatment cycle [Two and four weeks after completion of the first and second cycles, respectively]
Immunogenicity by incidence of anti-rIL-21 antibodies up to 1 month after treatment [During treatment and up to 1 month after completing treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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