drugset / Trial / NCT00988715

Donor Peripheral Blood Stem Cell Transplant and Pretargeted Radioimmunotherapy in Treating Patients With High-Risk Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome

NCT00988715

NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies pretargeted radioimmunotherapy and donor peripheral blood stem cell transplant employing fludarabine phosphate and total-body irradiation (TBI) to treat patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Giving chemotherapy drugs, such as fludarabine phosphate, and TBI before a donor peripheral blood stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies can be combined with fludarabine phosphate and TBI to find cancer cells and kill them without harming normal cells. Pretargeted radioimmunotherapy (PRIT) allows for further improved targeting of tumor cells over standard directly labeled antibodies.

Timeline

Start
2010-04-21
Primary completion
2015-01
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject BC8-SA Unknown Intravenous
Subject DOTA-biotin Other / unclassified Intravenous
Background Cyclosporine Peptide Intravenous
Background Fludarabine Small molecule Intravenous
Background Mycophenolate Mofetil Small molecule Oral