Ignite Creation Date:
2024-05-05 @ 10:13 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01050946
Status:
TERMINATED
Last Update Posted:
2015-11-20
First Post:
2010-01-14
Brief Title:
Hematopoietic Stem Cell Transplantation HSCT Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Phase II Study HSCT Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Only one patient was enrolled Due to low accrual study was terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HaploCord
Brief Summary:
This study is a means of providing transplantation to those patients who would be a stem cell transplant candidate who do not have an appropriate donor
The use of CD34 selected haploidentical donor with an umbilical cord unit may help provide earlier engraftment without the need for long term immunosuppression
This study tests a new method of bone marrow transplantation called combined haploidentical-cord blood transplantation In this procedure some of the blood forming cells the stem cells from a partially human leukocyte antigen HLA matched haploidentical related donor are collected from the blood as well as cells from an umbilical cord are transplanted into the patient the recipient after administration of a conditioning regimen A conditioning regimen consists of chemotherapy and sometimes radiation to the entire body total body irradiation or TBI which is meant to destroy the cancer cells and suppress the recipients immune system to allow the transplanted cells to take grow
The use of CD34 selected haploidentical donor with an umbilical cord unit may help provide earlier engraftment without the need for long term immunosuppression
This study tests a new method of bone marrow transplantation called combined haploidentical-cord blood transplantation In this procedure some of the blood forming cells the stem cells from a partially human leukocyte antigen HLA matched haploidentical related donor are collected from the blood as well as cells from an umbilical cord are transplanted into the patient the recipient after administration of a conditioning regimen A conditioning regimen consists of chemotherapy and sometimes radiation to the entire body total body irradiation or TBI which is meant to destroy the cancer cells and suppress the recipients immune system to allow the transplanted cells to take grow
Detailed Description:
This method of stem cell transplantation is designed to overcome some of the limitations of other alternative donor transplant options Use of unrelated umbilical cord unit UCB donors appears to allow a greater degree of HLA mismatch with acceptable rates of GVHD However when UCB transplant was studied in the adult population investigators discovered several limitations One major limitation with UCB was delayed engraftment resulting in higher risk of infection in the early post transplant period The limitations to cord blood transplant involve delayed engraftment resulting in early complications such as infections The main limitation associated with haploidentical donors is the significant immunosuppression required to preventtreat aGVHD Use of this combined modality of transplantation appears to allow for rapid neutrophil engraftment from the haploidentical donor and coupled with long term hematopoiesis from the UCB donor thus requiring less long term immunosuppression
This study tests a new method of bone marrow transplantation called combined haploidentical-cord blood transplantation In this procedure some of the blood forming cells the stem cells from a partially HLA matched haploidentical related donor are collected from the blood as well as cells from an umbilical cord are transplanted into the patient the recipient after administration of a conditioning regimen A conditioning regimen consists of chemotherapy and sometimes radiation to the entire body total body irradiation or TBI
One of two conditioning regimens which will be determined by the physician
1 FLUDARABINE MELPHALAN ATG
Fludarabine 30mgm2Days-7-6-5-4-3-Melphalan 70mgm2Day -3-2 ATG 15mgm2Day-7-5-3-1
2 FLUDARABINE BUSULFAN 400 CGY TBI ATG Fludarabine 50mgm2Day -6-5-4-3-2Busulfan 32mgkgDay -5-4-3-2 400cGY Total Body IrradiationTBIDay-1ATG 15mgkgDay-7-5-3-1
Day 0 -Haploidentical donor and one umbilical cord blood unit infusion
Filgrastim will be administered daily from day 1 until blood counts have completely recovered Tacrolimus and another immunosuppressant Cellcept starting before transplant also to reduce the risks of graft versus host disease and to promote the growth of the graft Tacrolimus will be given daily from two days before the transplant until at least three months after transplantation Cellcept will be tapered after the cells engraft
This study tests a new method of bone marrow transplantation called combined haploidentical-cord blood transplantation In this procedure some of the blood forming cells the stem cells from a partially HLA matched haploidentical related donor are collected from the blood as well as cells from an umbilical cord are transplanted into the patient the recipient after administration of a conditioning regimen A conditioning regimen consists of chemotherapy and sometimes radiation to the entire body total body irradiation or TBI
One of two conditioning regimens which will be determined by the physician
1 FLUDARABINE MELPHALAN ATG
Fludarabine 30mgm2Days-7-6-5-4-3-Melphalan 70mgm2Day -3-2 ATG 15mgm2Day-7-5-3-1
2 FLUDARABINE BUSULFAN 400 CGY TBI ATG Fludarabine 50mgm2Day -6-5-4-3-2Busulfan 32mgkgDay -5-4-3-2 400cGY Total Body IrradiationTBIDay-1ATG 15mgkgDay-7-5-3-1
Day 0 -Haploidentical donor and one umbilical cord blood unit infusion
Filgrastim will be administered daily from day 1 until blood counts have completely recovered Tacrolimus and another immunosuppressant Cellcept starting before transplant also to reduce the risks of graft versus host disease and to promote the growth of the graft Tacrolimus will be given daily from two days before the transplant until at least three months after transplantation Cellcept will be tapered after the cells engraft
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None