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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and severity of adverse events through 1 month after completing treatment

Outcome Time Frame:

During treatment and through 1 month after completing treatment

Safety Issue:

Yes

Principal Investigator

Muriel Siadak, PA-C

Investigator Role:

Study Director

Investigator Affiliation:

ZymoGenetics

Authority:

United States: Food and Drug Administration

Study ID:

494E03

NCT ID:

NCT00347971

Start Date:

June 2006

Completion Date:

April 2008

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Lymphoma, Non-Hodgkin
  • interleukin-21
  • rituximab
  • Immunotherapy
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

University of California, Los AngelesLos Angeles, California