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RecruitingObservational

Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy: Opportunities for T-Cell Directed Immunotherapy

NCT ID: NCT06279572Sponsor: Mayo ClinicLast updated: 2026-04-01

Summary

This study investigates the immune profile of patients receiving treatment with venetoclax plus azacitidine for acute myeloid leukemia (AML). Studying the information gathered from the immune profile from blood and bone marrow samples may help researchers understand the associated responses to the treatment of patients undergoing therapy of venetoclax plus azacitidine and create future immune based treatment approaches.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate immune profile of AML patients receiving venetoclax plus azacitidine induction chemotherapy. SECONDARY OBJECTIVE: I. To determine clinical responses based on immune infiltrated vs immune depleted subtypes of AML receiving azacitidine and venetoclax chemotherapy. OUTLINE: This is an observational study. Patients undergo blood sample collection and bone marrow aspirate on study. Patients' medical records are reviewed.

Arms & interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

  • ProcedureBone Marrow Aspirate

    Undergo bone marrow aspirate

  • OtherElectronic Health Record Review

    Medical records are reviewed

Outcome measures

Primary

  • Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy

    Assessed using additional biospecimen samples collected during standard of care procedures (10-15 ml of peripheral blood and 10 ml of bone marrow aspirate samples). Specimens will be cryopreserved and stored for cytometry.

    Time frame: Baseline (at enrollment)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Adults \> 18 yrs of age with diagnosis of acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy * Treatment naive adult acute myeloid leukemia patients Exclusion Criteria: * Acute myeloid leukemia patients receiving azacitidine and venetoclax as salvage therapy will be excluded * Patients who are pregnant or breast-feeding

Study locations (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

Not Yet Recruiting
Clinical Trials Referral Office · Contact
Cecilia Y. Arana Yi, M.D. · Principal Investigator

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

Recruiting
Clinical Trials Referral Office · Contact
Talha Badar, M.D. · Principal Investigator

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Not Yet Recruiting
Clinical Trials Referral Office · Contact
Mithun V. Shah, M.D., Ph.D. · Principal Investigator