drugset / Trial / NCT00309842

Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases

NCT00309842 ↗

Phase 2 Completed 213 enrolled Masonic Cancer Center, University of Minnesota
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells and prepares the patient's bone marrow for the 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 may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an umbilical cord blood transplant for hematologic cancer.

Timeline

Start
2005-07-28
Primary completion
2019-07-29
Completion
2019-11-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Subject Fludarabine Small molecule 25 mg/m2 Intravenous
Background Cyclosporine Peptide 2.5 mg/kg Intravenous
Background Mycophenolate Mofetil Small molecule 15 mg/kg Intravenous
Background Mycophenolate Mofetil Small molecule 3 g Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg Intravenous