Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
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.
Radiation: Total body irradiation
Biological: Stem cell transplant
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)|
- Time to Engraftment [ Time Frame: Day 42 ] [ Designated as safety issue: No ]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.
- Incidence of Graft Failure [ Time Frame: Day 42 ] [ Designated as safety issue: No ]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.
- Status of Donor Chimerism [ Time Frame: Day 100, 6 Months, 1 Year ] [ Designated as safety issue: No ]A state in bone marrow transplantation in which donor hematopoietic cells and host cells exist compatibly without signs of rejection.
- Incidence of Acute Graft-Versus-Host Disease (GVHD) [ Time Frame: Day 100 ] [ Designated as safety issue: Yes ]Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
- Change in Incidence of Chronic Graft-Versus-Host Disease (GVHD) [ Time Frame: 6 Months, 1 Year ] [ Designated as safety issue: Yes ]Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.
- Incidence of Transplant Related Mortality [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
- Incidence of Overall Survival [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
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.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Reduced Intensity Conditioning
Includes patients receiving a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using reduced intensity conditioning (RIC). Patients will receive busulfan, fludarabine, total body irradiation and stem cell transplant. Keppra will be given for seizure prophylaxis.
0.4 mg/kg (0.5 mg/kg if <4 years of age) intravenously (IV) every 6 hours on Days -8 and -7.
Other Name: BusulfexDrug: Fludarabine
40 mg/m^2 intravenously (IV) over 1 hour on days -6 through -2.
Other Name: FludaraRadiation: Total body irradiation
200 cGy on Day -1Biological: Stem cell transplant
stem cell infusion on day 0Drug: Keppra
Keppra will be given for seizure prophylaxis during busulfan administration as per the standard institutional protocol.
Other Name: Levetiracetam
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666080
|Contact: Weston P. Miller, M.D.||email@example.com|
|Contact: Teresa Kvisto, RNfirstname.lastname@example.org|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Weston P. Miller, M.D. 612-626-2778 email@example.com|
|Principal Investigator: Weston P. Miller, M.D.|
|Principal Investigator:||Weston P. Miller, M.D.||Masonic Cancer Center, University of Minnesota|