University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455, United States
Location status: Recruiting
NCT Number: NCT02161783
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.
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Observational
Minneapolis, Minnesota, 55455, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant.
Other names: Fludara
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.
TBI 200cGy in a single fraction on day -1 from transplant.
Other names: TBI
Hematopoietic stem cell infusion given on day 0.
Other names: HSCT
Time frame: day 42
Rate of sustained donor engraftment at day 42 post this transplant.
Time frame: day 100
Rate of treatment related mortality (TRM) at day 100
Time frame: Day 100
Rate of survival by day 100.
Time frame: 1 year
Rate of survival at 1 year
Time frame: Day 100
Incidence of acute graft-versus-host disease by day 100
Time frame: 1 year
Incidence of chronic graft-versus-host disease at 1 year.
Contact information is provided by the study sponsor or research team.
Masonic Cancer Center, University of Minnesota
Other
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