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

NCT06279572 | Recruiting DMC

• 1 other identifier: 20-011624
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

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.

  Baseline (at enrollment)

Study Arms (1)

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

Electronic Health Record Review OTHER

Medical records are reviewed

Observational (blood collection, bone marrow aspirate)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

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

Observational (blood collection, bone marrow aspirate)

Bone Marrow Aspirate PROCEDURE

Undergo bone marrow aspirate

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

Observational (blood collection, bone marrow aspirate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adults \> 18 yrs of age with diagnosis of acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy
• Treatment naive adult acute myeloid leukemia patients

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

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

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow and peripheral blood samples

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Specimen Handling; Fluid Therapy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Drug Therapy; Therapeutics

Study Officials

• Talha Badar, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: April 22, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (3)