Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fludarabine, Cyclophosphamide, Total Body Irradiation, Hematopoietic stem cell infusion.
- Who it may be relevant to
- Registry conditions: Primary Graft Failure, Secondary Graft Failure. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Fludarabine
Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant. - Drug 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.
Primary outcome measures
- Rate of donor engraftment [Time frame: day 42]
Secondary outcome measures (5)
- Rate of treatment related mortality [Time frame: day 100]
- Rate of survival [Time frame: Day 100]
- Rate of survival [Time frame: 1 year]
- Incidence of acute graft-versus-host disease [Time frame: Day 100]
- Incidence of chronic graft-versus-host disease [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Minnesota Medical Center, Fairview — Minneapolis
Identifiers
NCT: NCT02161783 · 2013OC003 · MT2013-06C