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NCT Number: NCT02161783

Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

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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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Timothy Krepski

CONTACT

[email protected]

612-273-2800

Troy C Lund, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with primary or secondary graft failure, as defined below, may receive a second transplant:
  • Primary graft failure is defined as not achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42 following the first transplant.
  • Secondary graft failure is defined as achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10^9/L without recovery.
  • Loss of chimerism is defined as achieving an ANC ≥0.5x10^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood.
  • Recipients should have acceptable organ function defined as:
  • Renal: creatinine < 2.0 (adults) and creatinine clearance > 30. For creatinine clearance < 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments.
  • Hepatic: bilirubin, AST/ALT, ALP < 10 x upper limit of normal
  • Cardiac: left ventricular ejection fraction > 40%

Exclusion criteria

  • Uncontrolled infection at the time of transplant.
  • Patients with Fanconi Anemia or other DNA breakage syndromes.

Treatment and study plan

Fludarabine

Drug

Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant.

Other names: Fludara

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.

Other names: TBI

Hematopoietic stem cell infusion

Biological

Hematopoietic stem cell infusion given on day 0.

Other names: HSCT

Primary outcomes

  1. Rate of donor engraftment

    Time frame: day 42

    Rate of sustained donor engraftment at day 42 post this transplant.

Secondary outcomes

  1. Rate of treatment related mortality

    Time frame: day 100

    Rate of treatment related mortality (TRM) at day 100

  2. Rate of survival

    Time frame: Day 100

    Rate of survival by day 100.

  3. Rate of survival

    Time frame: 1 year

    Rate of survival at 1 year

  4. Incidence of acute graft-versus-host disease

    Time frame: Day 100

    Incidence of acute graft-versus-host disease by day 100

  5. Incidence of chronic graft-versus-host disease

    Time frame: 1 year

    Incidence of chronic graft-versus-host disease at 1 year.

Study contacts

Contact information is provided by the study sponsor or research team.

Timothy Krepski

CONTACT

[email protected]

612-273-2800

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Important dates

Study start
2014
Primary completion
2032
Study completion
2032
First posted
Jun 12, 2014
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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