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

This study has been completed.
Sponsor:
Information provided by:
ZymoGenetics
ClinicalTrials.gov Identifier:
NCT00347971
First received: June 30, 2006
Last updated: September 4, 2008
Last verified: September 2008
  Purpose

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 Intervention Phase
Lymphoma, Non-Hodgkin
Drug: recombinant human interleukin 21 and rituximab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ZymoGenetics:

Primary Outcome Measures:
  • Incidence and severity of adverse events through 1 month after completing treatment [ Time Frame: During treatment and through 1 month after completing treatment ] [ Designated as safety issue: Yes ]
  • Incidence and grade of clinical laboratory abnormalities through 1 month after treatment [ Time Frame: During treatment and through 1 month after completing treatment ] [ Designated as safety issue: Yes ]

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 [ Time Frame: Two and four weeks after completion of the first and second cycles, respectively ] [ Designated as safety issue: No ]
  • Immunogenicity by incidence of anti-rIL-21 antibodies up to 1 month after treatment [ Time Frame: During treatment and up to 1 month after completing treatment ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: June 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: recombinant human interleukin 21 and rituximab
    rIL-21 (30, 100, 150 ug/kg) IV rituximab (375 mg/m2) IV
    Other Name: rituxan
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347971

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
ZymoGenetics
Investigators
Study Director: Muriel Siadak, PA-C ZymoGenetics
  More Information

No publications provided

Responsible Party: Muriel Siadak, ZymoGenetics
ClinicalTrials.gov Identifier: NCT00347971     History of Changes
Other Study ID Numbers: 494E03
Study First Received: June 30, 2006
Last Updated: September 4, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by ZymoGenetics:
Lymphoma, Non-Hodgkin
interleukin-21
rituximab
Immunotherapy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 23, 2014