Last updated on October 2017

Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases


Brief description of study

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.

Detailed Study Description

OBJECTIVES: Primary - Determine the 1-year survival of patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine, cyclophosphamide, and fractionated total-body irradiation. Secondary - Determine the incidence of transplant-related mortality at 6 months after UCBT. - Evaluate the pattern of chimerism after double UCBT. - Determine the incidence of neutrophil engraftment at day 42 after UCBT. - Determine the incidence of platelet engraftment at 6 months after UCBT. - Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT. - Determine the incidence of chronic GVHD at 1 year after UCBT. - Determine the disease-free survival at 1 and 2 years after UCBT. - Determine the incidence of relapse at 1 year after UCBT. OUTLINE: This is a nonrandomized, open-label, multicenter study. - Preparative Regimen: Patients receive fludarabine IV over 1 hour on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients also undergo total-body irradiation twice daily on days -4 to -1. - Umbilical Cord Blood Transplantation (UCBT): Patients undergo 1 or 2 units of UCBT on day 0. Patients receive filgrastim (G-CSF) IV once daily beginning on day 1 and continuing until blood counts recover. - Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2 hours 2 or 3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. Patients also receive mycophenolate mofetil IV or orally 2 or 3 times a day beginning on day -3 and continuing until day 30 or 7 days after engraftment in the absence of acute GVHD. After completion of study treatment, patients are followed periodically for at least 5 years. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Clinical Study Identifier: NCT00309842

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Clinical Trials Office - Masonic ...

Masonic Cancer Center at University of Minnesota
Minneapolis, MN United States
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Claudio G. Brunstein, M.D.

Fred Hutchinson Cancer Research Center
Seattle, WA United States
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