Clinical trial · Interventional
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
A Phase I/II Study: Zevalin Radioimmunotherapy for Patients With Post Transplant Lymphoproliferative Disease Following Solid Organ Transplantation
NCT00064246CI-TRIAL-00009133completedPhase 1 / Phase 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)
Phase I/II trial to study the effectiveness of combining yttrium Y 90 ibritumomab tiuxetan with rituximab in treating patients who have localized or recurrent lymphoproliferative disorder after an organ transplant. Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Post-transplant Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Recurrent Adult Burkitt Lymphoma | Adult Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Stage III Adult Burkitt Lymphoma | Adult Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Stage III Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Stage IV Adult Burkitt Lymphoma | Adult Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Stage IV Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Waldenström Macroglobulinemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indium In 111 ibritumomab tiuxetan | Radiation | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
| yttrium Y 90 ibritumomab tiuxetan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (rituximab, yttrium Y 90 ibritumomab tiuxetan)
- description
- Phase I: Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo 2 (or 3 if needed) imaging scans between days 1-6. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by IDEC-Y2B8 IV over 10 minutes on day 8. Phase II: Patients receive treatment as in phase I at the MTD of IDEC-Y2B8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.
- interventionNames
- Biological: rituximab
- Radiation: indium In 111 ibritumomab tiuxetan
- Radiation: yttrium Y 90 ibritumomab tiuxetan
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Up to 4 years
- description
- Estimated using binomial proportions and their 95% confidence intervals.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed post-transplant lymphoproliferative disorder (PTLD) of 1 of the following stages: * Stage III or IV * Localized (not amenable to localized radiotherapy or excision) * Recurrent * The following histologies\* are eligible: * Polyclonal PTLD * Monoclonal PTLD * Diffuse large B-cell non-Hodgkin's lymphoma (NHL) * Lymphoplasmacytic NHL * Burkitt/Burkitt-like NHL * Must not have completely responded during OR progressed after prior rituximab with or without chemotherapy * No history of rapid disease progression while receiving prior chemotherapy * Measurable disease * Must have less than 25% bone marrow involvement with lymphoma * Prior solid organ transplantation required * Evaluation of malignant cells for Epstein-Barr virus (EBV) required * EBV positive or negative allowed * No pleural effusion * No CNS lymphoma, including leptomeningeal disease * No pulmonary involvement by NHL in patients with prior lung transplantation * No HIV or AIDS-related lymphoma * No hypocellular bone marrow (i.e., less than 15% cellularity) * No marked reduction in bone marrow precursors of one or more cell lines (i.e., granulocytic, megakaryocytic, or erythroid) * Performance status - Karnofsky 50-100% * At least 3 months * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 150,000/mm\^3 * Bilirubin no greater than 2.5 mg/dL * Creatinine no greater than 2.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * HIV negative * No serious nonmalignant disease or infection that would compromise study objectives * No presence of antimurine antibody reactivity * No other concurrent active malignancy requiring therapy * More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) * More than 6 weeks since prior rituximab * No prior allogeneic bone marrow or hematopoietic stem cell transplantation * No prior radioimmunotherapy for NHL * More than 4 weeks since prior chemotherapy * See Biologic therapy * No prior radiotherapy to more than 25% of active bone marrow (involved field or regional) * More than 4 weeks since prior major surgery except diagnostic surgery * No other concurrent anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.