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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00347971
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : September 5, 2008
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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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

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

Primary Outcome Measures :
  1. Incidence and severity of adverse events through 1 month after completing treatment [ Time Frame: During treatment and through 1 month after completing treatment ]
  2. Incidence and grade of clinical laboratory abnormalities through 1 month after treatment [ Time Frame: During treatment and through 1 month after completing treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00347971

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

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Responsible Party: Muriel Siadak, ZymoGenetics Identifier: NCT00347971     History of Changes
Other Study ID Numbers: 494E03
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: September 2008

Keywords provided by ZymoGenetics:
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents