Recruiting

Cyclophosphamide & Fludarabine

Sponsor:

Masonic Cancer Center, University of Minnesota

Code:

NCT02161783

Conditions

Primary Graft Failure

Secondary Graft Failure

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Fludarabine

Cyclophosphamide

Total Body Irradiation

Hematopoietic stem cell infusion

Study Details

Brief 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

Study ID

NCT02161783

Start date

Oct 6, 2014

Status verified date

Jan, 2026

Completion date

Jan 30, 2032

Anticipated

Primary completion date

Jan 24, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment

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

Interventions

Fludarabine

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

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.

Total Body Irradiation

TBI 200cGy in a single fraction on day -1 from transplant.

Hematopoietic stem cell infusion

Hematopoietic stem cell infusion given on day 0.

Primary outcome measure

  • Rate of donor engraftment [ Time Frame: day 42 ]

Central Contacts and Locations

Central contacts

Timothy Krepski

612-273-2800tkrepsk1@fairview.org

Locations

University of Minnesota Medical Center, Fairview

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Timothy Krepski

612-273-2800tkrepsk1@fairview.org

Principal Investigator:

Troy C Lund, MD, PhD

More Information

Sponsor

Masonic Cancer Center, University of Minnesota

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Keywords

  • Hematopoietic stem cell transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota on 2026-01-06.