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NCT06279572 Clinical Trial

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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06279572
Other study ID # 20-011624
Secondary ID NCI-2022-0961820
Status Recruiting
Phase
First received
Last updated
Start date April 22, 2021
Est. completion date December 31, 2026

Study information
Verified date February 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo blood sample collection
• Bone Marrow Aspirate
Undergo bone marrow aspirate
Other:
• Electronic Health Record Review
Medical records are reviewed

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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. Baseline (at enrollment)
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