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Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA)

S

Suhu Liu

Status

Enrolling

Conditions

Acute Myeloid Leukemia

Treatments

Diagnostic Test: Quantification of blood cells positive for CLL1 and CD45RA surface markers by flow cytometry

Study type

Observational

Funder types

Other

Identifiers

NCT06297551
SBU-AML-LSC
IRB2023-00528 (Other Identifier)

Details and patient eligibility

About

Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow and the most common form of acute leukemia in adults. Patient with AML have the shortest survival compared to other forms of leukemia. In the past 6 years, several new therapies have been approved.

Biomarkers are in urgent need to guide therapeutic regimen selection in order to maximize the benefit of available therapies and minimize treatment toxicity. Current standard practice is to perform bone marrow biopsy at end of treatment cycle (each cycle around 28 days), and based on bone marrow finding, to decide further treatment plan. It is invasive and time consuming.

In this study investigators will study whether tracking leukemia stem cells (LSC) in peripheral blood during early treatment cycle may provide a non-invasive method to predict therapeutic outcome at end of treatment cycle. A retrospective study found that LSC fractional change, defined by two LSC markers, named CLL1 and CD45RA, is highly correlated with therapeutic outcome. Further more, CLL1 and CD45RA positive LSC fraction demonstrates a high concordance between bone marrow and peripheral blood, offering the opportunity to track CLL1 and CD45RA positive LSC fraction non-invasively in peripheral blood during treatment.

This pilot study will allow the investigators to decide whether testing CLL1 and CD45RA positive LSC in peripheral blood during leukemia treatment is feasible in clinical practice. This result will lay the foundation for designing future trials using CLL1 and CD45RA positive LSC fractional change to optimize therapeutic strategy for patients with AML.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • diagnosis of acute myeloid leukemia
  • ability to receive treatment for acute myeloid leukemia at the research center
  • elevated values of CLL1A and CD45RA positive cells at the time of diagnosis

Trial contacts and locations

1

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Central trial contact

Caterina Vacchi-Suzzi, PhD

Data sourced from clinicaltrials.gov

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