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Dose-Intense Yttrium-90 Ibritumomab Tiuxetan (Zevalin)-Containing Non-Myeloablative Conditioning for Allogeneic Stem Cell Transplantation in B-cell Malignancies
The goal of this clinical research study is to learn if adding Zevalin (ibritumomab tiuxetan) to low-intensity chemotherapy (the combination of rituximab, bendamustine, and fludarabine), followed by an allogeneic stem cell transplant, can help to control lymphoma. The safety of this combination will also be studied. Two (2) forms of ibritumomab tiuxetan will be used in this study. 90Y-ibritumomab tiuxetan is designed to attach to lymphoma cells and destroy the cells using a radioactive particle that is attached to it. 111In-ibritumomab tiuxetan is like 90Y- ibritumomab tiuxetan, but the radioactive particle that is attached to it does not kill lymphoma cells. The radioactive particle makes the drug able to be seen inside your body. It is being used in this study to predict how fast the study drug will travel in the body and how long the drug stays in the body. Rituximab is designed to attach to lymphoma cells, which may cause them to die. Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells. Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.
Details
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2013-01 |
| Completion | 2019-04-24 |
Conditions
- Leukemia
- Lymphoma
Interventions
- Rituximab
- 111In Ibritumomab
- Planar Scintigraphy Imaging
- 90Y IbritumomabTiuxetan
- Fludarabine
- Bendamustine
- Thymoglobulin
- Tacrolimus
- Methotrexate
- Mycophenolate
Primary outcomes
- Treatment-Related Mortality (TRM) — 100 days
Number of participants without treatment related mortality at day 100.
Countries
United States