Acute Myeloid Leukemia Clinical Trial
Official title:
Higher Percentage of CD34+ CD38- Cells Detected by Multiparameter Flow Cytometry From Leukapheresis Products Predicts Unsustained Complete Remission in Acute Myeloid Leukemia
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.
Status | Completed |
Enrollment | 123 |
Est. completion date | May 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 72 Years |
Eligibility |
Inclusion Criteria: - Age = 18 years - With a newly diagnosed de novo or secondary type AML (post myelodysplastic syndrome (MDS) or therapy-related AML) - Patients achieving first CR after induction or salvage therapy Exclusion Criteria: - Patients with acute promyelocytic leukemia (APL) - Concomitant uncontrolled infection, organ dysfunction or medical disease - left ventricular ejection fraction (LVEF) < 45% as assessed by echocardiography |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
France | Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet | Pierre-Bénite |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-free survival (EFS) | EFS was defined from date of first apheresis to the date of relapse or death, or last contact with the patient in continuous complete remission | During the study (1 year) | No |
Secondary | Overall survival (OS) | OS was defined as the time from first apheresis to death or last patient contact. For patients effectively autografted, OS and EFS were calculated from the date of autologous SCT | During the study (1 year) | No |
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