Leukemia Stem Cell Detection in Acute Myeloid Leukemia

Last updated: April 19, 2022
Sponsor: Wake Forest University Health Sciences
Overall Status: Terminated

Phase

3

Condition

Leukemia

Leukemia (Pediatric)

Treatment

N/A

Clinical Study ID

NCT02927938
LCI-HEM-AML-SCD-001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must have previously signed the specimen procurement protocol consent associated withthe leukemia stem cell assay ("Step 1 informed consent") prior to starting AMLtherapy.
  2. Age 18 years and older
  3. New diagnosis of AML, other than APL, confirmed by bone marrow aspirate/biopsy andreviewed by an institutional hematopathologist
  4. Completion of induction therapy, as defined by the Investigator and post-inductionbone marrow biopsy.

Exclusion

Exclusion Criteria:

  1. Any debilitating medical or psychiatric illness that would preclude ability to followstudy procedures.
  2. Indeterminate leukemia stem cell assay results at diagnosis.

Study Design

Total Participants: 18
Study Start date:
September 01, 2016
Estimated Completion Date:
October 05, 2018

Connect with a study center

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

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