Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
Completed · Phase 1/Phase 2
Conditions studied: Post-transplant Lymphoproliferative Disorder, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Waldenström Macroglobulinemia
In brief
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
Key facts
- Study ID
- NCT00064246
- Run by
- National Cancer Institute (NCI)
- People needed
- 28
- Starts
- 2003-07-01
- Last updated by the study team
- 2013-01-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- AIDS - Associated Malignancies Clinical Trials Consortium — Rockville, Maryland, United States
Full record on ClinicalTrials.gov
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