Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
- Conditions
- Secondary Graft FailurePrimary Graft Failure
- Interventions
- Radiation: Total Body IrradiationBiological: Hematopoietic stem cell infusion
- Registration Number
- NCT02161783
- Lead Sponsor
- Masonic Cancer Center, University of Minnesota
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
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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.
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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%
- Uncontrolled infection at the time of transplant.
- Patients with Fanconi Anemia or other DNA breakage syndromes.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment Hematopoietic stem cell infusion This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion. Treatment Total Body Irradiation This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion. Treatment Fludarabine This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion. Treatment Cyclophosphamide This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion.
- Primary Outcome Measures
Name Time Method Rate of donor engraftment day 42 Rate of sustained donor engraftment at day 42 post this transplant.
- Secondary Outcome Measures
Name Time Method Rate of treatment related mortality day 100 Rate of treatment related mortality (TRM) at day 100
Incidence of acute graft-versus-host disease Day 100 Incidence of acute graft-versus-host disease by day 100
Rate of survival 1 year Rate of survival at 1 year
Incidence of chronic graft-versus-host disease 1 year Incidence of chronic graft-versus-host disease at 1 year.
Trial Locations
- Locations (1)
University of Minnesota Medical Center, Fairview
🇺🇸Minneapolis, Minnesota, United States