Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT02161783|
Recruitment Status : Recruiting
First Posted : June 12, 2014
Last Update Posted : September 30, 2020
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.
|Condition or disease||Intervention/treatment|
|Primary Graft Failure Secondary Graft Failure||Drug: Fludarabine Drug: Cyclophosphamide Radiation: Total Body Irradiation Biological: Hematopoietic stem cell infusion|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion.
Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant.
Other Name: Fludara
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.
Other Name: TBI
Biological: Hematopoietic stem cell infusion
Hematopoietic stem cell infusion given on day 0.
Other Name: HSCT
- Rate of donor engraftment [ Time Frame: day 42 ]Rate of sustained donor engraftment at day 42 post this transplant.
- Rate of treatment related mortality [ Time Frame: day 100 ]Rate of treatment related mortality (TRM) at day 100
- Rate of survival [ Time Frame: Day 100 ]Rate of survival by day 100.
- Rate of survival [ Time Frame: 1 year ]Rate of survival at 1 year
- Incidence of acute graft-versus-host disease [ Time Frame: Day 100 ]Incidence of acute graft-versus-host disease by day 100
- Incidence of chronic graft-versus-host disease [ Time Frame: 1 year ]Incidence of chronic graft-versus-host disease at 1 year.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161783
|Contact: Timothy Krepskiemail@example.com|
|United States, Minnesota|
|University of Minnesota Medical Center, Fairview||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Timothy Krepski 612-273-2800 firstname.lastname@example.org|
|Principal Investigator: Troy C Lund, MD, PhD|
|Principal Investigator:||Troy C Lund, MD, PhD||University of Minnesota|