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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (blood collection, bone marrow aspirate) | Patients undergo blood sample collection and bone marrow aspirate on study. Patients' medical records are reviewed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Talha Badar, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Not yet recruiting | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Bone marrow and peripheral blood samples
| Bone Marrow Aspirate | Procedure | Undergo bone marrow aspirate |
|
|
| Electronic Health Record Review | Other | Medical records are reviewed |
|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224-9980 | United States |
|
| Mayo Clinic in Rochester | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
|
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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