Trials / Completed

CompletedNCT00719888

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

Transplantation of Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation or Cyclophosphamide/Fludarabine/Thiotepa/Total Body Irradiation Myeloablative Preparative Regimen

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 135 (actual)

Sponsor: Fred Hutchinson Cancer Center · Academic / Other
Sex: All
Age: 6 Months – 65 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic disease. Giving chemotherapy, such as cyclophosphamide and fludarabine, 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 description

OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients receive myeloablative conditioning comprising fludarabine intravenously (IV) over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI twice daily (BID) on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. ARM II: Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI once daily (QD) on days -2 and -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.

Conditions

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Given IV
DRUG	Cyclosporine	Given IV and PO
PROCEDURE	Double-Unit Umbilical Cord Blood Transplantation	Undergo double-unit UCBT
DRUG	Fludarabine	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Mycophenolate Mofetil	Given IV and PO
RADIATION	Total-Body Irradiation	Undergo high-dose or moderate-intensity TBI
PROCEDURE	Umbilical Cord Blood Transplantation	Undergo UCBT
DRUG	Thiotepa	Given IV

Timeline

Start date: 2005-11-18
Primary completion: 2023-12-22
Completion: 2024-12-19
First posted: 2008-07-22
Last updated: 2025-03-07
Results posted: 2025-03-07

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00719888. Inclusion in this directory is not an endorsement.