NCT02161783

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
70mo left

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Oct 2014Jan 2032

First Submitted

Initial submission to the registry

June 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

October 6, 2014

Completed
17.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2032

Expected
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2032

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

17.3 years

First QC Date

June 10, 2014

Last Update Submit

January 2, 2026

Conditions

Primary Graft FailureSecondary Graft Failure

Keywords

Hematopoietic stem cell transplant

Outcome Measures

Primary Outcomes (1)

  • Rate of donor engraftment

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

    day 42

Secondary Outcomes (5)

  • Rate of treatment related mortality

    day 100

  • Rate of survival

    Day 100

  • Rate of survival

    1 year

  • Incidence of acute graft-versus-host disease

    Day 100

  • Incidence of chronic graft-versus-host disease

    1 year

Study Arms (1)

Treatment

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

Drug: FludarabineDrug: CyclophosphamideRadiation: Total Body IrradiationBiological: Hematopoietic stem cell infusion

Interventions

FludarabineDRUG

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

Also known as: Fludara
Treatment
CyclophosphamideDRUG

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.

Treatment
Total Body IrradiationRADIATION

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

Also known as: TBI
Treatment
Hematopoietic stem cell infusionBIOLOGICAL

Hematopoietic stem cell infusion given on day 0.

Also known as: HSCT
Treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Graft failure for

You may qualify if:

  • 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%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Interventions

fludarabinefludarabine phosphateCyclophosphamideWhole-Body IrradiationStem Cell Transplantation

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsRadiotherapyTherapeuticsInvestigative TechniquesCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTransplantationSurgical Procedures, Operative

Study Officials

  • Troy C Lund, MD, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Krepski

CONTACT

612-273-2800tkrepsk1@fairview.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 12, 2014

Study Start

October 6, 2014

Primary Completion (Estimated)

January 24, 2032

Study Completion (Estimated)

January 30, 2032

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations

US(1)