Ignite Creation Date:
2024-05-06 @ 1:28 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01810588
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-11
First Post:
2013-01-07
Brief Title:
Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
A Prospective Study of Optimal Cord Selection for Haplo-Cord Transplantation Targeting the Inherited Paternal Antigen IPA and Matching for the Non-Inherited Maternal Antigen NIMA
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this trial we aim to improve the outcomes of haplo cord transplant Haplo cord transplant is a novel and promising way to improve transplant outcomes We hypothesize that identification of a graft that is at least 56 matched and inherited paternal antigen IPA targeted ie cord blood grafts share one or more IPA antigens with the prospective recipient is more important to the outcome of haplo cord transplant than the nucleated cell dose The identification of such a graft for a large proportion of the subjects may necessitate accepting a lower umbilical cord graft dose
In addition to a umbilical cord blood transplant recipients will receive stem cells from a family member a haplo-identical donor After collection and prior to infusion these cells will be purified using a device called a CliniMACS CD34 selection device The subject will undergo a chemotherapy conditioning regimen prior to transplantation No experimental drugs are used in this study and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past
In addition to a umbilical cord blood transplant recipients will receive stem cells from a family member a haplo-identical donor After collection and prior to infusion these cells will be purified using a device called a CliniMACS CD34 selection device The subject will undergo a chemotherapy conditioning regimen prior to transplantation No experimental drugs are used in this study and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past
Detailed Description:
This is a clinical trial for subjects with hematologic malignancies acute leukemia myeloproliferative disorders lymphoma myeloma who are in need of a donor stem cell transplant and for whom an umbilical cord blood transplant is thought to be the best option As donors for allogeneic transplant we typically try to use related family members such as brothers or sisters or volunteer donors who are HLA matched ie share similar proteins on their cells This study is for subjects for whom such a matched sibling donor or a matched unrelated donor is not available
For such subjects a commonly used transplant procedure is to use stem cells from one or two umbilical cords UCB from a newborn These umbilical cord blood grafts despite not completely matching the recipient cause few problems with graft vs host disease a common complication of transplant But they tend to grow very slowly and subjects often have very prolonged hospital stays and are at high risk for complications due to low blood counts Umbilical cord blood transplant will be the standard arm for this protocol
This study uses a new method of bone marrow transplantation called combined haplo-identical cord haplo-cord transplantation In this procedure cells from a related donor who shares half of the HLA proteins haplo-identical are collected from the blood as well as cells from an umbilical cord and then both are transplanted It is hoped that by using cells from a haplo-identical relative subjects will have a faster recovery and require fewer transfusions Over time the haplo-identical cells from the relative are replaced by the cells from the cord blood The combined transplantation of haplo-identical stem cells and cord blood has previously been used in approximately 60 subjects with very encouraging results
Traditionally it has been felt that the most important determinant of outcome of an UCB stem cell transplant is the cord blood cell dose The second determinant is the degree of matching between donor and recipient Many times we have difficulty identifying UCB units of sufficient cell dose that are well matched Of interestin our prior study of haplo-cord SCT indicated outcomes seemed independent of the UCB cell dose If this preliminary observation is correct we may be able to improve the outcomes of haplo cord transplant further by accepting lower threshold UCB doses and rather focusing on optimal matching including matching for HLA and another characteristic called IPA This is the primary objective of this study
For such subjects a commonly used transplant procedure is to use stem cells from one or two umbilical cords UCB from a newborn These umbilical cord blood grafts despite not completely matching the recipient cause few problems with graft vs host disease a common complication of transplant But they tend to grow very slowly and subjects often have very prolonged hospital stays and are at high risk for complications due to low blood counts Umbilical cord blood transplant will be the standard arm for this protocol
This study uses a new method of bone marrow transplantation called combined haplo-identical cord haplo-cord transplantation In this procedure cells from a related donor who shares half of the HLA proteins haplo-identical are collected from the blood as well as cells from an umbilical cord and then both are transplanted It is hoped that by using cells from a haplo-identical relative subjects will have a faster recovery and require fewer transfusions Over time the haplo-identical cells from the relative are replaced by the cells from the cord blood The combined transplantation of haplo-identical stem cells and cord blood has previously been used in approximately 60 subjects with very encouraging results
Traditionally it has been felt that the most important determinant of outcome of an UCB stem cell transplant is the cord blood cell dose The second determinant is the degree of matching between donor and recipient Many times we have difficulty identifying UCB units of sufficient cell dose that are well matched Of interestin our prior study of haplo-cord SCT indicated outcomes seemed independent of the UCB cell dose If this preliminary observation is correct we may be able to improve the outcomes of haplo cord transplant further by accepting lower threshold UCB doses and rather focusing on optimal matching including matching for HLA and another characteristic called IPA This is the primary objective of this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None