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

Recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspirate; Other: Electronic Health Record Review

• Registration Number: NCT06279572
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2021-04-22
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (blood collection, bone marrow aspirate)	Bone Marrow Aspirate	Patients undergo blood sample collection and bone marrow aspirate on study. Patients' medical records are reviewed.
Observational (blood collection, bone marrow aspirate)	Electronic Health Record Review	Patients undergo blood sample collection and bone marrow aspirate on study. Patients' medical records are reviewed.
Observational (blood collection, bone marrow aspirate)	Biospecimen Collection	Patients undergo blood sample collection and bone marrow aspirate on study. Patients' medical records are reviewed.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States