Recruiting

Azacitidine & Venetoclax

Sponsor:

Mayo Clinic

Code:

NCT06279572

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Bone Marrow Aspirate

Electronic Health Record Review

Study Details

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

Study ID

NCT06279572

Start date

Apr 22, 2021

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (blood collection, bone marrow aspirate)

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

Interventions

Biospecimen Collection

Undergo blood sample collection

Bone Marrow Aspirate

Undergo bone marrow aspirate

Electronic Health Record Review

Medical records are reviewed

Primary outcome measure

  • Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy [ Time Frame: Baseline (at enrollment) ]

Central Contacts and Locations

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Talha Badar, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-01.