Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
Location status: Recruiting
Location contact
Weston P. Miller, M.D.
CONTACT
Weston P. Miller, M.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT01666080
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.
Interested in participating?
Request InfoUp to 55 year
All sexes
Interventional
Not applicable
Minneapolis, Minnesota, 55455, United States
Location status: Recruiting
Weston P. Miller, M.D.
CONTACT
Weston P. Miller, M.D.
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
At the discretion of the treating transplant physician, an allograft from the previous donor may be used, if available.
Exclusion criteria
0.4 mg/kg (0.5 mg/kg if <4 years of age) intravenously (IV) every 6 hours on Days -8 and -7.
Other names: Busulfex
40 mg/m^2 intravenously (IV) over 1 hour on days -6 through -2.
Other names: Fludara
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.
Other names: Levetiracetam
Time frame: Day 42
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
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 100, 6 Months, 1 Year
A state in bone marrow transplantation in which donor hematopoietic cells and host cells exist compatibly without signs of rejection.
Time frame: Day 100
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
Time frame: 6 Months, 1 Year
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
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
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.
Contact information is provided by the study sponsor or research team.
Paul Orchard, M.D.
CONTACT
Troy Lund, M.D., Ph.D.
CONTACT
Masonic Cancer Center, University of Minnesota
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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