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RecruitingNCT06279572Updated Apr 1, 2026

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

An observational study in Acute Myeloid Leukemia, sponsored by Mayo Clinic. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Myeloid Leukemia
03

In context

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's planned enrollment of 80 is below the median of 120 across 317 observational studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy.

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

Exclusion Criteria:

  • Acute myeloid leukemia patients receiving azacitidine and venetoclax as salvage therapy will be excluded
  • Patients who are pregnant or breast-feeding
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observational (blood collection, bone marrow aspirate)

    Patients undergo blood sample collection and bone marrow aspirate on study. Patients' medical records are reviewed.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspirate · Other: Electronic Health Record Review

Interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

  • ProcedureBone Marrow Aspirate

    Undergo bone marrow aspirate

    Also known as: BONE MARROW, LIQUID, Human Bone Marrow Aspirate

  • OtherElectronic Health Record Review

    Medical records are reviewed

06

What researchers measure

Primary outcomes

  1. 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)

07

Study locations

1 of 3 sites recruiting
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
    Not yet recruiting
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
    Recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    Not yet recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06279572
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Feb 28, 2024
Start date
Apr 22, 2021
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 1, 2026

Study contacts

Talha Badar, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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