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

NCT06297551 | Recruiting

• 2 other identifiers: SBU-AML-LSCIRB2023-00528
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Interventions

Quantification of blood cells positive for CLL1 and CD45RA surface markers by flow cytometry DIAGNOSTIC_TEST

During induction therapy for AML, researchers will measure the relative percentage of hematopoietic stem cells (defined by markers CD34+/CD38-) that test positive for CLL1 and CD45RA surface markers in the blood of participants on day 3, 5 and 7 days of systemic therapy. The variation of blood cells positivity for these markers, will be correlated with treatment outcome (complete response, partial response, no response), as determined by a bone marrow biopsy done approximately 4 weeks after induction chemotherapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with acute myeloid leukemia, undergoing systemic chemotherapy (high or low intensity)

You may qualify if:

• 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

Sponsors & Collaborators

• Suhu Liu: lead

Study Sites (1)

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Suhu Liu, MD PhD

  Stony Brook Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caterina Vacchi-Suzzi, PhD

CONTACT

631-728-7425; cancerclinicaltrials@stonybrookmedicine.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 7, 2024
• Study Start: May 17, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)