Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04635384
Status:
RECRUITING
Last Update Posted:
2022-07-19
First Post:
2020-10-28
Brief Title:
Assessment of Chimerism and Relapse Post Bone MarrowHematopoietic Cell Transplant HCT Using AlloHeme Test
Sponsor:
CareDx
Organization:
CareDx
Study Overview
Official Title:
Assessment of Chimerism and Relapse Post Bone MarrowHCT Transplant Using AlloHeme Test ACROBAT
Status:
RECRUITING
Status Verified Date:
2022-07
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:
ACROBAT
Brief Summary:
AlloHeme is a chimerism test service that utilizes NGS technology to analyze SNP loci to quantify donor and recipient cells by measuring genomic DNA Before transplant patient and donor peripheral blood sample will be collected to identify informative marker for routine chimerism testing and baseline establishment for AlloHeme Post-transplant blood or bone marrow samples are obtained and compared to the baseline sample profiles to calculate chimerism of recipient cells in the blood andor bone marrow samples Cell selection from blood and bone marrow samples is applied to evaluate chimerism in specific cell subtypes that are relevant to AML and MDS diseases CD3 T lymphocytes CD33 Myeloid cells and CD15 Granulocyte cell subtypes from blood and CD34 hematopoietic stem cells from bone marrow
Detailed Description:
The test will be started from month 1 post HCT and will be performed bi-weekly up to month 3 monthly from month 4-6 and quarterly from month 9 to year 2 for total 15 visits During each visit about 18 ml 36 teaspoons of whole blood will be collected into 3 pink BD Hemogard tubes with K2 EDTA additive In addition to blood collection the subject will be asked to provide 3ml or 06 teaspoon of bone marrow specimens during the routine visits on Day 100month 3 Day 180 and Day 360 for use in this research study When bone marrow study is performed marrow specimen will be collected for AlloHeme test at central lab Standard chimerism assessment bone marrow study and MRD test will be performed at each participated institution lab as clinically indicated and based on treating physicians discretion Method of standard of care chimerism and MRD assessment will be based on each institutional standard protocol Data related to AlloHeme test clinical outcomes PHI and all standard of care of patient management information will be collected from medical records During the Baseline and pre transplant the following clinical data will be collected sex age donor and recipient demographic chemotherapy remission status pre-transplant donor type HLA stem cell source conditioning regimen type and intensity cytogenetics test minimal residual disease chimerism T cell depletion and GVHD protocol Following transplantation clinical events including death relapse second allo-HSCT DLI as well as the events that impact the chimerism like tapering IST GVHD and infection will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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