Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

Last updated: December 18, 2024
Sponsor: Masonic Cancer Center, University of Minnesota
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Hematopoietic stem cell infusion

Total Body Irradiation

Cyclophosphamide

Clinical Study ID

NCT02161783
2013OC003
MT2013-06C
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with primary or secondary graft failure, as defined below, may receive asecond transplant:

  • Primary graft failure is defined as not achieving an ANC ≥0.5x10^9/L for threeconsecutive days by day 35 - 42 following the first transplant.

  • Secondary graft failure is defined as achieving an ANC ≥0.5x10^9/L for threeconsecutive days by day 35 - 42, but subsequently drops below 0.5x10^9/Lwithout recovery.

  • Loss of chimerism is defined as achieving an ANC ≥0.5x10^9/L for threeconsecutive, but with less than 10% CD15+ donor cells in the marrow orperipheral blood.

  • Recipients should have acceptable organ function defined as:

  • Renal: creatinine < 2.0 (adults) and creatinine clearance > 30. For creatinineclearance < 70, consultation with a BMT pharmacist is necessary forchemotherapy dose adjustments.

  • Hepatic: bilirubin, AST/ALT, ALP < 10 x upper limit of normal

  • Cardiac: left ventricular ejection fraction > 40%

Exclusion

Exclusion Criteria:

  • Uncontrolled infection at the time of transplant.

  • Patients with Fanconi Anemia or other DNA breakage syndromes.

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Hematopoietic stem cell infusion
Phase:
Study Start date:
October 06, 2014
Estimated Completion Date:
January 30, 2032

Connect with a study center

  • University of Minnesota Medical Center, Fairview

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

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