Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT02161783
Status
Recruiting
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Conditions

  • Primary Graft Failure
  • Secondary Graft Failure

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant.
  • Cyclophosphamide — DRUG
    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.
  • Total Body Irradiation — RADIATION
    TBI 200cGy in a single fraction on day -1 from transplant.
  • Hematopoietic stem cell infusion — BIOLOGICAL
    Hematopoietic stem cell infusion given on day 0.

Study Details

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 Dates

Start date
Oct 6, 2014
Status verified
Jan 2026
Primary completion
Jan 24, 2032
Completion
Jan 30, 2032

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Treatment
    This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion.

Primary Outcome Measure

Rate of donor engraftment [ Time Frame: day 42 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Minnesota Medical Center, FairviewMinneapolisMinnesota55455
Timothy Krepski
[email protected]
612-273-2800
Troy C Lund, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Minneapolis, MN

By research site
University of Minnesota Medical Center, Fairview· Minneapolis, MN

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