Health TrialsbyHealthPanel

Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

ConditionsPrimary Graft FailureSecondary Graft Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMasonic Cancer Center, University of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Renal: creatinine < 2.0 (adults) and creatinine clearance > 30. For creatinine clearance < 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments.

Disqualifiers

Uncontrolled infection at the time of transplant.

Patients with Fanconi Anemia or other DNA breakage syndromes.

Trial population

Graft failure for

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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/Vaccine

    Hematopoietic stem cell infusion given on day 0.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Treatment4 interventions

Trial outcomes

Primary outcomes

1

Rate of donor engraftment

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

Time frame
day 42

Secondary outcomes

1

Rate of treatment related mortality

Rate of treatment related mortality (TRM) at day 100

Time frame
day 100
2

Rate of survival

Rate of survival by day 100.

Time frame
Day 100
3

Rate of survival

Rate of survival at 1 year

Time frame
1 year
4

Incidence of acute graft-versus-host disease

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

Time frame
Day 100

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masonic Cancer Center, University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
Apply now