Clinical trial · Interventional
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
NCT00347971CI-TRIAL-00001667completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant human interleukin 21 and rituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Incidence and severity of adverse events through 1 month after completing treatment
- timeFrame
- During treatment and through 1 month after completing treatment
- measure
- Incidence and grade of clinical laboratory abnormalities through 1 month after treatment
- timeFrame
- During treatment and through 1 month after completing treatment
Secondary outcomes (2)
- measure
- Disease response by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas 2 weeks after completion of the first treatment cycle
- timeFrame
- Two and four weeks after completion of the first and second cycles, respectively
- measure
- Immunogenicity by incidence of anti-rIL-21 antibodies up to 1 month after treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.