Acute Myeloid LeukemiaNCT06279572
Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy
An observational study of Acute Myeloid Leukemia, run by Mayo Clinic at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Biospecimen Collection, Bone Marrow Aspirate and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Apr 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy.
Who may be able to join
- Adults > 18 yrs of age with diagnosis of acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy
- Treatment naive adult acute myeloid leukemia patients
Who cannot join
- Acute myeloid leukemia patients receiving azacitidine and venetoclax as salvage therapy will be excluded
- Patients who are pregnant or breast-feeding
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Talha Badar, M.D.
- Not yet recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Mithun V. Shah, M.D., Ph.D.
- Not yet recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Cecilia Y. Arana Yi, M.D.
About this study
Official title: Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy: Opportunities for T-Cell Directed Immunotherapy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate immune profile of AML patients receiving venetoclax plus azacitidine induction chemotherapy.
SECONDARY OBJECTIVE:
- 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
- Acute Myeloid Leukemia
- Being tested
- Biospecimen Collection, Bone Marrow Aspirate, Electronic Health Record Review
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Bone Marrow AspirateProcedure or surgery
Also called BONE MARROW, LIQUID, Human Bone Marrow Aspirate
Undergo bone marrow aspirate
Electronic Health Record ReviewOther
Medical records are reviewed
| Study group | Role | What they receive |
|---|---|---|
| Observational (blood collection, bone marrow aspirate) | Patients undergo blood sample collection and bone marrow aspirate on study. Patients' medical records are reviewed. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspirate; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start22 Apr 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Talha Badar, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279572
- Sponsor's protocol ID
- 20-011624
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy: Opportunities for T-Cell Directed Immunotherapy
- ClinicalTrials.gov ID
- NCT06279572
- Acronym / sponsor ID
- 20-011624
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVE:
- To evaluate immune profile of AML patients receiving venetoclax plus azacitidine induction chemotherapy.
SECONDARY OBJECTIVE:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (blood collection, bone marrow aspirate) | – | Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspirate, Other: Electronic Health Record ReviewPatients undergo blood sample collection and bone marrow aspirate on study. Patients' medical records are reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy.
Key inclusion criteria (2 listed)
- Adults > 18 yrs of age with diagnosis of acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy
- Treatment naive adult acute myeloid leukemia patients
Key exclusion criteria (2 listed)
- Acute myeloid leukemia patients receiving azacitidine and venetoclax as salvage therapy will be excluded
- Patients who are pregnant or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Observational (blood collection, bone marrow aspirate) |
| Bone Marrow AspirateAlso: BONE MARROW, LIQUID, Human Bone Marrow AspirateUndergo bone marrow aspirate | Procedure or surgery | Observational (blood collection, bone marrow aspirate) |
| Electronic Health Record ReviewMedical records are reviewed | Other | Observational (blood collection, bone marrow aspirate) |
Primary outcome
Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy
Time frame: Baseline (at enrollment)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Talha Badar, M.D. principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy (time frame: Baseline (at enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.