Clinical trial · Interventional
Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Phase I/II Study of Two Sequential Doses of IDEC-Y2B8 in Patients With Relapsed Low-Grade and Follicular Non-Hodgkin's Lymphoma
NCT00012298CI-TRIAL-00034245terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial completed prematurely.
Summary
Brief summary (as posted)
Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibody therapy and rituximab with and without filgrastim and interleukin-11 in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal antibodies can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Biological therapies such as filgrastim and interleukin-11 use different ways to stimulate the immune system and stop cancer cells from growing.
Conditions
Conditions (9)
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 Grade 3 Follicular Lymphoma | Grade 3 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Marginal Zone Lymphoma | Marginal Zone Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| indium In 111 ibritumomab tiuxetan | Biological | — | UNRESOLVED |
| oprelvekin | Biological | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
| yttrium Y 90 ibritumomab tiuxetan | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (radiolabeled monoclonal antibody therapy)
- description
- Patients receive rituximab IV on days 1 and 8, indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1, and yttrium Y 90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) and interleukin-11 SC until blood counts recover.
- interventionNames
- Biological: rituximab
- Biological: yttrium Y 90 ibritumomab tiuxetan
- Biological: indium In 111 ibritumomab tiuxetan
- Biological: oprelvekin
- Biological: filgrastim
Primary outcomes (3)
- measure
- Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I)
- timeFrame
- At 8 weeks
- description
- This study is a series of 3 single-arm phase-I trials designed to determine the maximum tolerated dose (MTD) of a 2-cycle combination regimen containing Rituxan + Y2B8 radioimmunotherapy with and without the use of G-CSF and IL-11. Trial 1 will determine the Y2B8 MTD in the combined regimen without growth factors. Trial 2 will evaluate the combined regimen with growth factors. Trial 3 starts IL-11 earlier (when platelet count drops below 150000) and reduces the dosing interval to twice weekly. \> Dose-limiting toxicity (DLT) is defined as an adverse event in the second cycle attributed to treatment and meeting the following criteria: Grade 4 ANC or platelet decrease for 14 days, or grade 3 for 28 days, or any other grade 3 Non-Heme event. \> If at any time 2 or more patients (of a maximum of 6) at any dose level experience DLT, then the MTD will be defined as the previous dose level during that trial. The number of patients with a DLT are reported here.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven relapsed or refractory low-grade or follicular CD+ non-Hodgkin lymphoma, including 1 of the following: * Small lymphocytic lymphoma * Lymphoplasmacytoid lymphoma * Follicular center lymphoma (grades I, II, and III) * Extranodal marginal zone B-cell lymphoma * Nodal marginal zone B-cell lymphoma * Splenic marginal zone B-cell lymphoma (monocytoid B-cell lymphoma) * Less than 25% bone marrow involvement of cellular marrow with lymphoma by bilateral bone marrow aspirate and biopsy * ECOG performance status 0-2 * Bidimensionally measurable disease with at least 1 lesion \>= 2 cm in the greatest diameter * No prior myeloablative therapy with autologous or allogeneic bone marrow transplantation or peripheral blood stem cell support * No concurrent corticosteroid therapy, except prednisone (or equivalent) for adrenal failure or \< 20mg of prednisone daily * No prior external beam radiotherapy to \>25% of active bone marrow * More than 4 weeks since prior surgery other than diagnostic surgery * No other concurrent myelosuppressive antineoplastic agents * No prior radioimmunotherapy, including yttrium Y 90 ibritumomab tiuxetan or iodine I 131 monoclonal antibody tositumomab or Lym-1 * No CNS lymphoma * No myelodysplastic syndromes or marrow chromosomal changes suggesting myelodysplasia * No HIV or AIDS-related lymphoma * No pleural effusion or ascites with lymphoma cells * No active infection * No other serious non-malignant disease that would preclude study participation * No other active primary malignancy * No known human anti-mouse or human anti-chimeric antibody * No prior skin rash (e.g., Stevens-Johnsons syndrome or toxic epidermal necrolysis) from rituximab therapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Absolute neutrophil count \>= 1,500/mm\^3 * Platelet count \>= 150,000/mm\^3 * Total lymphocyte count \< 5,000/mm\^3 for patients with small lymphocytic lymphoma * Bilirubin =\< 2 mg/dL * Creatinine =\< 2 mg/dL
References
Publications (0)
Data not yet available
No reference posted for this study.