Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01666080|
Recruitment Status : Recruiting
First Posted : August 16, 2012
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Disorders Hemoglobinopathies Immunodeficiencies||Drug: Busulfan Drug: Fludarabine Radiation: Total body irradiation Biological: Stem cell transplant Drug: Keppra||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
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
- Time to Engraftment [ 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.
- Incidence of Graft Failure [ 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.
- Status of Donor Chimerism [ 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.
- Incidence of Acute Graft-Versus-Host Disease (GVHD) [ 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.
- Change in Incidence of Chronic Graft-Versus-Host Disease (GVHD) [ 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.
- Incidence of Transplant Related Mortality [ 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.
- Incidence of Overall Survival [ 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666080
|Contact: Troy Lund, M.D., Ph.D.||firstname.lastname@example.org|
|Contact: Paul Orchard, M.D.||email@example.com|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Weston P. Miller, M.D. 612-626-2778 firstname.lastname@example.org|
|Principal Investigator: Weston P. Miller, M.D.|
|Principal Investigator:||Troy Lund, M.D., Ph.D.||Masonic Cancer Center, University of Minnesota|