NCT02161783

Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Graft Failure
• Secondary Graft Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-10-06
• Primary completion: 2032-01-24
• Completion: 2032-01-30
• First posted: 2014-06-12
• Last updated: 2026-01-06

Locations

1 site across 1 country: United States