Leukemia Stem Cell Detection in Acute Myeloid Leukemia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/6/2019 |
| Start Date: | September 2016 |
| End Date: | September 2022 |
Most patients with acute myeloid leukemia (AML) achieve complete remission (CR) following
induction chemotherapy. However, a large majority subsequently relapse and succumb to the
disease. Currently, cytogenetics and molecular aberrations are the best prognostic
indicators; however, these factors cannot prognosticate accurately for individual patients.
Overall, the majority of patients with favorable or intermediate-risk AML will experience
relapse. Prognosis after relapse is dismal with a five-year overall survival rate of less
than 10%. A leukemia stem cell (LSC) paradigm may explain this failure of CR to reliably
translate into cure. This study is undertaken to determine whether the presence of LSCs has
prognostic value as well as to determine whether the presence of LSCs has predictive value.
This study has an observational component, whereby we intent evaluate whether the presence or
absence of LSCs is prognostic. This study also has an interventional component in which it
uses LSC status to determine whether favorable and intermediate risk AML patients in CR
receive consolidation with chemotherapy or allogeneic HCT.
induction chemotherapy. However, a large majority subsequently relapse and succumb to the
disease. Currently, cytogenetics and molecular aberrations are the best prognostic
indicators; however, these factors cannot prognosticate accurately for individual patients.
Overall, the majority of patients with favorable or intermediate-risk AML will experience
relapse. Prognosis after relapse is dismal with a five-year overall survival rate of less
than 10%. A leukemia stem cell (LSC) paradigm may explain this failure of CR to reliably
translate into cure. This study is undertaken to determine whether the presence of LSCs has
prognostic value as well as to determine whether the presence of LSCs has predictive value.
This study has an observational component, whereby we intent evaluate whether the presence or
absence of LSCs is prognostic. This study also has an interventional component in which it
uses LSC status to determine whether favorable and intermediate risk AML patients in CR
receive consolidation with chemotherapy or allogeneic HCT.
Inclusion Criteria:
1. Must have previously signed the specimen procurement protocol consent associated with
the leukemia stem cell assay ("Step 1 informed consent") prior to starting AML
therapy.
2. Age 18 years and older
3. New diagnosis of AML, other than APL, confirmed by bone marrow aspirate/biopsy and
reviewed by an institutional hematopathologist
4. Completion of induction therapy, as defined by the Investigator and post-induction
bone marrow biopsy.
Exclusion Criteria:
1. Any debilitating medical or psychiatric illness that would preclude ability to follow
study procedures.
2. Indeterminate leukemia stem cell assay results at diagnosis.
We found this trial at
1
site
Click here to add this to my saved trials
