This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) in patients with non-malignant or malignant diseases. This regimen, consisting of busulfan, fludarabine, and low dose total body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve an acceptable level of donor-derived engraftment following a previous allogeneic HCT.
There is no research element except the collection of routine clinical data. Patients will consent to allow routine clinical data to be collected and maintained in OnCore, the Masonic Cancer Center's (MCC) clinical database, and specific transplant related endpoints in the University Of Minnesota Blood and Bone Marrow Database as part of the historical database maintained by the department.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
0.4 mg/kg (0.5 mg/kg if \<4 years of age) intravenously (IV) every 6 hours on Days -8 and -7.
40 mg/m\^2 intravenously (IV) over 1 hour on days -6 through -2.
200 cGy on Day -1
stem cell infusion on day 0
Keppra will be given for seizure prophylaxis during busulfan administration as per the standard institutional protocol.
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGTime to Engraftment
Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm3 (0.5 x 109/L) or greater.
Time frame: Day 42
Incidence of Graft Failure
Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
Time frame: Day 42
Status of Donor Chimerism
A state in bone marrow transplantation in which donor hematopoietic cells and host cells exist compatibly without signs of rejection.
Time frame: Day 100, 6 Months, 1 Year
Incidence of Acute Graft-Versus-Host Disease (GVHD)
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
Time frame: Day 100
Change in Incidence of Chronic Graft-Versus-Host Disease (GVHD)
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.
Time frame: 6 Months, 1 Year
Incidence of Transplant Related Mortality
In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
Time frame: 6 Months
Incidence of Overall Survival
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease. Also called survival rate. Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive.
Time frame: 6 Months
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