Ignite Creation Date:
2024-05-06 @ 2:31 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02061800
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2014-02-11
Brief Title:
CD34 Malignant Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant
Sponsor:
Diane George
Organization:
Columbia University
Study Overview
Official Title:
CD34 Stem Cell Selection for Patients Receiving a Matched or Partially Matched Family or Unrelated Adult Donor Allogeneic Stem Cell Transplant for Malignant Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
The purpose of this study is to learn more about the effects of classification determinant CD34 stem cell selection on graft versus host disease GVHD in children adolescents and young adults CD34 stem cells are the cells that make all the types of blood cells in the body GVHD is a condition that results from a reaction of transplanted donor T-lymphocytes a kind of white blood cell against the recipients body and organs Study subjects will be offered treatment involving the use of the CliniMACS Reagent System Miltenyi Biotec a CD34 selection device to remove T-cells from a peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD
This study involves subjects who are diagnosed with a malignant disease that has either failed standard therapy or is unlikely to be cured with standard non-transplant therapy who will receive a peripheral blood stem cell transplant A malignant disease includes the following Chronic Myeloid Leukemia CML in chronic phase accelerated phase or blast crisis Acute Myelogenous Leukemia AML Myelodysplastic Syndrome MDS Juvenile Myelomonocytic Leukemia JMML Acute Lymphoblastic Leukemia ALL or Lymphoma Hodgkins and Non-Hodgkins
This study involves subjects who are diagnosed with a malignant disease that has either failed standard therapy or is unlikely to be cured with standard non-transplant therapy who will receive a peripheral blood stem cell transplant A malignant disease includes the following Chronic Myeloid Leukemia CML in chronic phase accelerated phase or blast crisis Acute Myelogenous Leukemia AML Myelodysplastic Syndrome MDS Juvenile Myelomonocytic Leukemia JMML Acute Lymphoblastic Leukemia ALL or Lymphoma Hodgkins and Non-Hodgkins
Detailed Description:
Graft versus host disease GVHD is one of the serious complications following allogeneic stem cell transplantation The incidence and severity of GVHD increase with the degree of HLA incompatibility between the host and donor The most reliable way to prevent acute and chronic GVHD is to remove T cells from the graft However the incidence of graft failure increases with the efficiency of T cell depletion and low T cell numbers are predictive of graft failure Immunomagnetic selection of HLA-mismatched CD34 progenitor cells has demonstrated high levels of T cell depletion and successful engraftment in adult and pediatric patients with the malignant and nonmalignant disease
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