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

NCT ID: NCT06279572

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-22

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (blood collection, bone marrow aspirate)

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

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Bone Marrow Aspirate

Intervention Type PROCEDURE

Undergo bone marrow aspirate

Electronic Health Record Review

Intervention Type OTHER

Medical records are reviewed

Interventions

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Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Bone Marrow Aspirate

Undergo bone marrow aspirate

Intervention Type PROCEDURE

Electronic Health Record Review

Medical records are reviewed

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection BONE MARROW, LIQUID Human Bone Marrow Aspirate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Talha Badar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status NOT_YET_RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Clinical Trials Referral Office

Role: primary

855-776-0015

Clinical Trials Referral Office

Role: primary

855-776-0015

Related Links

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Other Identifiers

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NCI-2022-09618

Identifier Type: REGISTRY

Identifier Source: secondary_id

20-011624

Identifier Type: OTHER

Identifier Source: secondary_id

20-011624

Identifier Type: -

Identifier Source: org_study_id

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