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

NCT ID: NCT06297551

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2026-05-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suhu Liu

OTHER

Sponsor Role: lead

Responsible Party

Suhu Liu

Assistant Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Suhu Liu, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook Medicine

Locations

Stony Brook Cancer Center

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Caterina Vacchi-Suzzi, PhD

Role: CONTACT

cancerclinicaltrials@stonybrookmedicine.edu

631-728-7425

Facility Contacts

Caterina Vacchi-Suzzi, PhD

Role: primary

cancerclinicaltrials@stonybrookmedicine.edu

631-728-7425

Other Identifiers

IRB2023-00528

Identifier Type: OTHER

Identifier Source: secondary_id

SBU-AML-LSC

Identifier Type: -

Identifier Source: org_study_id