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

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Mayo Clinic

Status

Enrolling

Conditions

Acute Myeloid Leukemia

Treatments

Procedure: Bone Marrow Aspirate
Procedure: Biospecimen Collection
Other: Electronic Health Record Review

Study type

Observational

Funder types

Other

Identifiers

NCT06279572
20-011624 (Other Identifier)
NCI-2022-09618 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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