Study of Recombinant Interleukin 21 in Combination With Rituxan for Non-Hodgkin's Lymphoma
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
1 other identifier
interventional
23
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 30, 2006
CompletedFirst Posted
Study publicly available on registry
July 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedSeptember 5, 2008
September 1, 2008
1.8 years
June 30, 2006
September 4, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Interventions
rIL-21 (30, 100, 150 ug/kg) IV rituximab (375 mg/m2) IV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZymoGeneticslead
Study Sites (1)
University of California, Los Angeles
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Muriel Siadak, PA-C
ZymoGenetics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2006
First Posted
July 4, 2006
Study Start
June 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
September 5, 2008
Record last verified: 2008-09