drugset / Trial / NCT00686556

Total Marrow Irradiation for Refractory Acute Leukemia

NCT00686556

Phase 1 Completed 12 enrolled Masonic Cancer Center, University of Minnesota
Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving chemotherapy and total marrow irradiation before a donor umbilical cord blood or hematopoietic stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of total marrow irradiation when given together with combination chemotherapy and umbilical cord blood hematopoietic stem cell transplant in treating patients with acute leukemia, acute myeloid leukemia or multiple myeloma that did not respond to previous therapy.

Timeline

Start
2012-08
Primary completion
2016-11
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Background Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Background Cyclosporine Peptide Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background Granulocyte colony-stimulating factor Protein / enzyme biologic 5 ug/kg Intravenous
Background Mycophenolate Mofetil Small molecule 15 mg/kg Intravenous
Background Mycophenolate Mofetil Small molecule 3 g Intravenous