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Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

NCT02161783 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-01-06

No results posted yet for this 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.

Conditions

  • Primary Graft Failure
  • Secondary Graft Failure

Interventions

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.

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.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Troy C Lund, MD, PhD · University of Minnesota

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-06
Primary Completion
2032-01-24
Completion
2032-01-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02161783 on ClinicalTrials.gov