Ignite Creation Date:
2024-05-06 @ 8:52 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02842112
Status:
COMPLETED
Last Update Posted:
2016-07-25
First Post:
2016-07-20
Brief Title:
Higher Percentage of CD34 CD38- Cells Detected by Multiparameter Flow Cytometry From Leukapheresis Products Predicts Unsustained Complete Remission in Acute Myeloid Leukemia
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Higher Percentage of CD34 CD38- Cells Detected by Multiparameter Flow Cytometry From Leukapheresis Products Predicts Unsustained Complete Remission in Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2016-07
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:
None
Brief Summary:
Over recent decades improvements have been made in the treatment of adult acute myeloid leukemia AML This has been mainly attributed to improvements in supportive therapy and to intensification of treatment strategies The introduction of a post-induction myeloablative regimen followed by allogeneic stem cell transplant SCT has reduced the relapse rate in younger adults However this procedure is limited by the availability of human leukocyte antigen HLA-identical donors and conventional SCT preparative regimens according to patient age In the absence of a compatible donor myeloablative chemotherapy followed by autologous peripheral blood PB SCT remains one treatment strategy in adult patients with AML allowing 35 - 50 long-term survivors Despite several advantages of the CD34 cell mobilization procedure recent data have shown that relapse was higher and leukemia-free survival LFS shorter compared with bone marrow BM autografts Higher doses of CD34 peripheral blood stem cells PBSCs are collected to ensure engraftment and possibly reduce the incidence of treatment-related mortality TRM Although there is a threshold CD34 cell dose below which engraftment is delayed in AML the positive linear correlation of the number of CD34 cells and kinetics of engraftment reaches a limit above which an increase in the number of progenitor cells does not provide any additional benefit Relapse has been shown to be higher and survival shorter for those who receive the highest CD34 PB doses Although highly active against the leukemia bulk intensive chemotherapy often spares the hardiest leukemia stem cells LSCs responsible for relapse Detection of minimal residual disease MRD in autologous PBSC products may reflect inadequate in vivo purging at least in part responsible for relapse Although representing a heterogeneous cell population including both normal and leukemia cells and despite that recent data have challenged the CD34 CD38- phenotype of LSCs in AML the CD34 CD38- cell population generally remains considered enriched for LSCs
In this setting MRD remaining during morphological complete remission CR should be relatively enriched in CD34 CD38- leukemia cells and their persistence after CR achievement should correlate with disease recurrence This was investigated in a cohort of 123 patients with AML following apheresis procedures after CR achievement The investigators also studied the impact of the infused dose of subpopulations of CD34 PB cells on the outcome of a subset of 71 patients who further underwent autologous PBSCT
In this setting MRD remaining during morphological complete remission CR should be relatively enriched in CD34 CD38- leukemia cells and their persistence after CR achievement should correlate with disease recurrence This was investigated in a cohort of 123 patients with AML following apheresis procedures after CR achievement The investigators also studied the impact of the infused dose of subpopulations of CD34 PB cells on the outcome of a subset of 71 patients who further underwent autologous PBSCT
Detailed Description:
None
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