Last updated on March 2018

Umbilical Cord Blood Transplant Cyclophosphamide Fludarabine Phosphate and Total-Body Irradiation in Treating Patients With Hematologic Disease


Brief description of study

This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine phosphate, and total-body irradiation (TBI) works in treating patients with hematologic disease. Giving chemotherapy, such as cyclophosphamide and fludarabine phosphate, and TBI before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps 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 transplant may stop this from happening.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To determine the one year survival of patients undergoing umbilical cord blood transplantation (UCBT) after a myeloablative preparative regimen consisting of cyclophosphamide (CY), fludarabine phosphate (fludarabine [FLU]), and fractionated total body irradiation (TBI).

SECONDARY OBJECTIVES:

I. Incidence of transplant-related mortality (TRM) at 6 months.

II. Chimerism at multiple time points.

III. Incidence of neutrophil engraftment at day 42.

IV. Incidence of platelet engraftment 6 months.

V. Incidence of acute graft-versus-host disease (GVHD) grade II-IV and grade III-IV at day 100.

VI. Incidence of chronic GVHD at day 100, 1 year and 2 years.

VII. Incidence of clinically significant infections at 6 months, 1 year and 2 years.

VIII. Incidence of disease free survival at 1 and 2 years.

IX. Incidence of relapse at 1 and 2 years.

OUTLINE

Patients receive myeloablative conditioning comprising fludarabine phosphate intravenously (IV) over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo TBI twice daily (BID) on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0.

Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine orally (PO) (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) three times daily (TID) on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred > day 30) after engraftment if there continues to be no evidence of acute GVHD.

After completion of study treatment, patients are followed up at 6 months, 1 year, and 2 years.

Clinical Study Identifier: NCT00719888

Contact Investigators or Research Sites near you

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University of Colorado Hospital
Aurora, CO United States
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Thomas R. Chauncey

VA Puget Sound Health Care System
Seattle, WA United States
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Ann E. Dahlberg

Fred Hutch/University of Washington Cancer Consortium
Seattle, WA United States
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