Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

Primary Graft Failure Clinical Trial

Official title:

Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02161783
• Other study ID #: 2013OC003
• Secondary ID: MT2013-06C
• Status: Recruiting
• Start date: October 6, 2014
• Est. completion date: January 30, 2032

Study information

• Verified date: December 2023
• Source: Masonic Cancer Center, University of Minnesota
• Contact: Timothy Krepski
• Phone: 612-273-2800
• Email: tkrepsk1[@]fairview.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 30, 2032
• Est. primary completion date: January 24, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Primary Graft Failure
• Secondary Graft Failure

Intervention

Drug:
• 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.

Radiation:
• Total Body Irradiation
TBI 200cGy in a single fraction on day -1 from transplant.

Biological:
• Hematopoietic stem cell infusion
Hematopoietic stem cell infusion given on day 0.

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of donor engraftment	Rate of sustained donor engraftment at day 42 post this transplant.	day 42
Secondary	Rate of treatment related mortality	Rate of treatment related mortality (TRM) at day 100	day 100
Secondary	Rate of survival	Rate of survival by day 100.	Day 100
Secondary	Rate of survival	Rate of survival at 1 year	1 year
Secondary	Incidence of acute graft-versus-host disease	Incidence of acute graft-versus-host disease by day 100	Day 100
Secondary	Incidence of chronic graft-versus-host disease	Incidence of chronic graft-versus-host disease at 1 year.	1 year