Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06279572

Enrollment

Registered

2024-02-28

Start date

2021-04-22

Completion date

2027-12-31

Last updated

2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Brief 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.

Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspirate

Undergo bone marrow aspirate

OTHERElectronic Health Record Review

Medical records are reviewed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy	Baseline (at enrollment)	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTalha Badar, M.D.

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026