Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480506
Status:
COMPLETED
Last Update Posted:
2012-02-23
First Post:
2007-05-30
Brief Title:
Monitoring of Erythroid Lineage Specific Chimerism Following Allogeneic Hematopoietic Transplantation for Thalassemia Major
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Monitoring of Erythroid Lineage Specific Chimerism Following Allogeneic Hematopoietic Transplantation for Thalassemia Major
Status:
COMPLETED
Status Verified Date:
2012-02
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 collect peripheral blood and bone marrow aspirate samples from thalassemia patients in Tehran in a collaborative effort to develop an erythroid lineage specific chimerism assay applicable to patients with thalassemia Development of such an assay would be useful both for identification of the exact mutation causing the disease as well as for providing a direct method to measure and monitor the kinetics of donor erythropoiesis in this patient population following transplant
Detailed Description:
In the first phase of the study we will develop a panel of reagents designed to identify predominant thalassemia mutations in the Iranian population as well as alternative highly variable erythroid specific polymorphisms To determine how informative this panel is these reagents will be applied to samples collected from patients homozygous for the disorder and compared to patients with thalassemia trait and normal Iranian donors
In the second phase we propose to serially measure and compare erythroid lineage chimerism with overall genomic chimerism following transplant Samples will be collected from participants before and at 1 2 3 6 and 12 months following transplant and cryopreserved Peripheral blood from the stem cell donor will also be collected and cryopreserved Participants will undergo myeloablative or nonmyeloablative transplant
In the second phase we propose to serially measure and compare erythroid lineage chimerism with overall genomic chimerism following transplant Samples will be collected from participants before and at 1 2 3 6 and 12 months following transplant and cryopreserved Peripheral blood from the stem cell donor will also be collected and cryopreserved Participants will undergo myeloablative or nonmyeloablative transplant
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