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RECRUITING
NCT02161783

Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

Sponsor: Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

Summary

This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure. The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a haploidentical related donor. The source of stem cells will be determined by the transplant team based on factors such as patient's age, medical history, donor availability and will be according to the current University of Minnesota Blood and Marrow Transplantation Program selection guidelines.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2014-10-06

Completion Date

2032-01-30

Last Updated

2026-01-06

Healthy Volunteers

No

Interventions

DRUG

Fludarabine

Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant.

DRUG

Cyclophosphamide

Cyclophosphamide 14.5 mg/kg IV over 1-2 hours given on days -6 and -5 from transplant. And Cyclophosphamide 50 mg/kg IV over 2 hours given on days +3 and +4 from transplant.

RADIATION

Total Body Irradiation

TBI 200cGy in a single fraction on day -1 from transplant.

BIOLOGICAL

Hematopoietic stem cell infusion

Hematopoietic stem cell infusion given on day 0.

Locations (1)

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, United States