Clinical trial · Interventional
Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer
A Phase I Trial Of Rituximab And Interleukin-2
NCT00010192CI-TRIAL-00010636completedPhase 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)
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-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells. Phase I trial to study the effectiveness of rituximab plus interleukin-2 in treating patients who have hematologic cancer.
Conditions
Conditions (53)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Adult Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| 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 |
| Noncontiguous Stage II Adult Burkitt Lymphoma | — | UNRESOLVED | — |
| Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma | — | UNRESOLVED | — |
| Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma | — | UNRESOLVED | — |
| Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma | — | UNRESOLVED |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (rituximab and aldesleukin)
- description
- Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin SC on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84.
- interventionNames
- Biological: rituximab
- Biological: aldesleukin
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- MTD defined as the dose preceding that at which at least 2 of 6 patients experience DLT using NCI CTC version 2.0
- timeFrame
- 2 weeks
- description
- Data collected will be descriptive and provide limited estimates of variability given the small sample sizes at each dose level.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or immunophenotypically proven CD20-positive B-cell lymphoproliferative disorder * Recurrent or progressive low-grade B-cell lymphoma with at least one prior chemotherapy regimen (may have included monoclonal antibody) * Relapsed intermediate-grade or high-grade B-cell lymphoma or B-lineage acute lymphoblastic leukemia and patient not a candidate for, refused, or failed prior hematopoietic stem cell transplantation * No chronic lymphocytic leukemia or lymphoma with more than 5,000/mm3circulating lymphoma cells * Measurable or evaluable disease * Must have failed standard curative therapy * No CNS or leptomeningeal metastasis * Performance status - Karnofsky 70-100% * Performance status - ECOG 0-1 * At least 4 months * Absolute neutrophil count at least 1,000/mm\^3 * Hemoglobin at least 10 g/dL (transfusion allowed) * Platelet count at least 50,000/mm\^3 * AST no greater than upper limit of normal (ULN) * Bilirubin no greater than 1.5 times ULN * Hepatitis B surface antigen negative * Creatinine no greater than ULN * No prior unstable coronary artery disease * No New York Heart Association class III or IV congestive heart failure * DLCO and FEV1 at least 50% of predicted * HIV negative * No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix * No infection requiring IV antibiotic therapy within the past 4 weeks * No other major illness that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * See Disease Characteristics * Prior antibody therapy allowed * Prior interleukin-2 or interferon alfa allowed * See Disease Characteristics * At least 4 weeks since prior chemotherapy * At least 4 weeks since prior systemic corticosteroids * At least 4 weeks since prior radiotherapy * At least 4 weeks since prior surgery
References
Publications (0)
Data not yet available
No reference posted for this study.