Ignite Creation Date:
2024-05-06 @ 2:03 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01966367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2013-10-17
Brief Title:
CD34 Non-Malignant Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation
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 Transplantation for Non-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:
This studys goal is to determine the frequency and severity of acute graft versus host disease to evaluate incidence of primary and secondary graft rejection to assess event free survival and overall survival to determine the time to neutrophil and platelet engraftment to determine the time to immune reconstitution including normalization of T B and natural killer NK cell repertoire and Immunoglobulin G production and to establish the incidence of infectious complications including bacterial viral fungal and atypical mycobacterial and other infections following CD34 selection in children adolescents and young adults receiving an allogeneic peripheral blood stem cell transplant from a family member or unrelated adult donor for a non-malignant disease
Detailed Description:
Graft-versus-host disease GVHD is a condition that results from a reaction of transplanted donor T-lymphocytes against the body and organs of the patient receiving the transplanted cells There are two forms acute early and chronic late Acute GVHD may produce skin rashes liver disease diarrhea and an increased risk of infection Chronic GVHD can appear in patients without prior acute GVHD Chronic GVHD may also produce skin rashes liver disease diarrhea and an increased risk of infection GVHD can make patients very sick and have GVHD can make it more likely that patients will not survive their transplant In this study the investigators are offering to treat the donor peripheral blood stem cells in the hope that it will make it less likely for the patient who receives them from having GVHD
Patients on this study are being offered an experimental treatment involving the use of the CliniMACS Reagent System Miltenyi Biotec Germany a CD34 selection device to remove T-cells from the peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD CD34 stem cells are selected from the donors peripheral blood stem cells In doing this T-cells are also removed T-cells are the cells which are responsible for graft versus host disease GVHD This study is a clinical trial for patients diagnosed with a non-malignant disease who will receive a peripheral blood stem cell transplant Patients with the following types of non-malignant diseases can participate in this study Bone marrow failure syndromes including Severe Aplastic Anemia Severe Congenital Neutropenia Amegakaryocytic Thrombocytopenia Kostmanns Syndrome Diamond-Blackfan Anemia Schwachman Diamond Syndrome Primary Immunodeficiency Syndromes Acquired Immunodeficiency Syndromes and Histiocytic Disorders and Hemoglobinopathies including Sickle Cell Anemia and SickleBeta Thalassemia Patients on this study will be given standard transplant therapy with either high doses of chemotherapy drugs or lower doses of chemotherapy drugs depending on their disease Diseases within each disease group will receive chemotherapy that is standard for that condition
Some patients on this study will receive an allogeneic stem cell transplant AlloSCT from a matched related donor If a patient does not have a matched related donor a bone marrow search will be done at all of the bone marrow banks in the world The patient will then go on to receive an AlloSCT from either a partially matched family member or an unrelated adult stem cell transplant donor The transplanted cells will allow all the normal parts of the patients blood system to recover The experimental portion of this treatment involves the use of a Miltenyi CliniMACS CD34 selection device to remove T-cells from the peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD CD34 stem cell selection AlloSCT has been studied in adults with the malignant and non-malignant disease with successful engraftment and has shown some improvement in GVHD It is unknown if CD34 stem cell selection will work to prevent severe GVHD in children and adolescents
Patients on this study are being offered an experimental treatment involving the use of the CliniMACS Reagent System Miltenyi Biotec Germany a CD34 selection device to remove T-cells from the peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD CD34 stem cells are selected from the donors peripheral blood stem cells In doing this T-cells are also removed T-cells are the cells which are responsible for graft versus host disease GVHD This study is a clinical trial for patients diagnosed with a non-malignant disease who will receive a peripheral blood stem cell transplant Patients with the following types of non-malignant diseases can participate in this study Bone marrow failure syndromes including Severe Aplastic Anemia Severe Congenital Neutropenia Amegakaryocytic Thrombocytopenia Kostmanns Syndrome Diamond-Blackfan Anemia Schwachman Diamond Syndrome Primary Immunodeficiency Syndromes Acquired Immunodeficiency Syndromes and Histiocytic Disorders and Hemoglobinopathies including Sickle Cell Anemia and SickleBeta Thalassemia Patients on this study will be given standard transplant therapy with either high doses of chemotherapy drugs or lower doses of chemotherapy drugs depending on their disease Diseases within each disease group will receive chemotherapy that is standard for that condition
Some patients on this study will receive an allogeneic stem cell transplant AlloSCT from a matched related donor If a patient does not have a matched related donor a bone marrow search will be done at all of the bone marrow banks in the world The patient will then go on to receive an AlloSCT from either a partially matched family member or an unrelated adult stem cell transplant donor The transplanted cells will allow all the normal parts of the patients blood system to recover The experimental portion of this treatment involves the use of a Miltenyi CliniMACS CD34 selection device to remove T-cells from the peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD CD34 stem cell selection AlloSCT has been studied in adults with the malignant and non-malignant disease with successful engraftment and has shown some improvement in GVHD It is unknown if CD34 stem cell selection will work to prevent severe GVHD in children and adolescents
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