NCT06297551

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

Prospective Study of Leukemia Stem Cells Fractional Change in Peripheral Blood and Its Correlation With Therapeutic Outcome in Acute Myeloid Leukemia
Suhu Liu·ClinicalTrials.gov·diagnostic testRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Acute Myeloid Leukemia
Drug/Device/Intervention
Quantification of blood cells positive for CLL1 and CD45RA surface markers by flow cytometry
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Suhu Liu
Funder
Stony Brook University
Location
Stony Brook, United States of America
Timeline & enrollment
Phase
N/A
Start date
Mar 05, 2024
End date
May 31, 2025
Enrollment
20 participants
Primary outcome

Concordance between the relative fraction of Leukemia Stem Cells (LSC) vs Hematopoietic Stem Cells (HSC) and treatment response

Summary

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. The research we are proposing here is to investigate 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. Our retrospective study have
 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 us 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.

ICD-10 classifications
Myeloid leukaemiaAcute myeloblastic leukaemia [AML]Myeloid leukaemia, unspecifiedAcute myelomonocytic leukaemiaAcute myeloid leukaemia with 11q23-abnormality
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06297551
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06297551 through Pure Global AI's free database. This phase not specified trial is sponsored by Suhu Liu and is currently Recruiting. The study focuses on Acute Myeloid Leukemia. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.