Clinical trial · Interventional
Rituximab and Interleukin-12 in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
Randomized Phase II Study Of Interleukin-12 In Combination With Rituximab In Patients With Non-Hodgkin's Lymphoma
NCT00026182CI-TRIAL-00011843completedPhase 2ClinicalTrials.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)
Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-12 may kill more cancer cells. This randomized phase II trial is comparing how well giving rituximab together with two different schedules of interleukin-12 works in treating patients with B-cell non-Hodgkin lymphoma.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Recurrent Grade 1 Follicular Lymphoma | Grade 1 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Grade 2 Follicular Lymphoma | Grade 2 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| recombinant interleukin-12 | Biological | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (rituximab and recombinant interleukin-12)
- description
- Patients receive rituximab IV on days 1, 8, 15, and 22. Patients receive interleukin-12 SC twice weekly beginning on day 2 and continuing until disease progression.
- interventionNames
- Biological: rituximab
- Biological: recombinant interleukin-12
- Other: laboratory biomarker analysis
- Other: questionnaire administration
- Procedure: quality-of-life assessment
- type
- EXPERIMENTAL
- label
- Arm II (rituximab and recombinant interleukin-12)
- description
- Patients receive rituximab as in arm I. Patients are evaluated at week 12. Patients with stable or progressive disease receive interleukin-12 SC twice weekly until disease progression or for 24 weeks. Patients with a complete or partial response after rituximab are monitored until disease progression and then begin interleukin-12 SC twice weekly until further disease progression.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma * Previously treated low-grade lymphoma considered incurable with standard therapy * Grade I or II follicular lymphoma\* * Lymphoplasmacytic lymphoma\* * Small lymphocytic lymphoma\* * Nodal marginal zone lymphoma\* * Extranodal marginal zone lymphoma of MALT type\* * Splenic marginal zone lymphoma\* * Previously treated mantle cell lymphoma allowed * Meets one of the following criteria for measurable disease: * Bidimensional diameter at least 1.5 cm by 1.5 cm on physical exam * At least 2 cm in one dimension by CT scan, MRI, or plain radiograph imaging * Palpable spleen at least 5 cm below the left costal margin * No CNS involvement by lymphoma * Performance status - ECOG 0-1 * At least 12 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Hemoglobin ≥ 8 g/dL * Bilirubin ≤ 3 times upper limit of normal (ULN) * AST and ALT ≤ 3 times ULN * Alkaline phosphatase ≤ 3 times ULN * Creatinine ≤ 2 times ULN * No New York Heart Association class III or IV heart disease * No history of angina * No uncontrolled peptic ulcer disease * No uncontrolled infection * No other active malignancy * No autoimmune-related phenomena (e.g., antinuclear antibody less than 2 times ULN, rheumatoid factor less than 2 times ULN, and negative direct Coombs) * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Prior stem cell transplantation allowed * More than 12 months since prior rituximab * No prior interleukin-12 * No other concurrent immunotherapy * Recovered from prior chemotherapy * No concurrent chemotherapy * No concurrent steroid therapy * No concurrent radiotherapy * Any number of prior therapies allowed
References
Publications (0)
Data not yet available
No reference posted for this study.