Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy: Opportunities for T-Cell Directed Immunotherapy
Study analyzes immune response to AML treatment
Plain English Summary
Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy is a Not Applicable clinical trial sponsored by Mayo Clinic studying Acute Myeloid Leukemia. This study looks at how the immune system responds in patients with a specific type of leukemia (AML) when they receive a combination of two drugs: azacitidine and venetoclax. It is for adults over 18 years old who have been newly diagnosed with acute myeloid leukemia and are starting treatment with azacitidine and venetoclax. Participation involves providing blood and bone marrow samples, and allowing researchers to review your medical records. Currently, there are no alternative treatments being tested within this specific study; it focuses on understanding the immune response to the standard treatment. The trial aims to enroll 80 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older diagnosed with acute myeloid leukemia who are about to start treatment with azacitidine and venetoclax. Patients who have not received prior treatment for their acute myeloid leukemia. Individuals who are pregnant or breastfeeding cannot participate. Patients receiving azacitidine and venetoclax as a second-line treatment (salvage therapy) are also not eligible. This trial is studying Acute Myeloid Leukemia, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures the immune system's 'fingerprint' before treatment begins, helping doctors understand how the body might fight the leukemia with the given drugs. The specific primary outcome measures are: Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy (Baseline (at enrollment)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it aims to understand how the immune system reacts to a common AML treatment, which could lead to new ways to boost the body's own defenses against cancer. This research targets Acute Myeloid Leukemia, where improved treatment options are needed.
Investor Insight
This observational study provides insights into the immune landscape of AML patients treated with a standard combination therapy, potentially informing the development of future immunotherapies in a s
Is This Trial Right for Me?
Ask your doctor if this study is right for you and what the potential benefits and risks are. Participation involves routine procedures like blood draws and bone marrow aspiration, which will be explained by the study team. Your medical information will be reviewed to gather data on your treatment and immune response. This trial is currently recruiting participants. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 80 participants
Interventions
- PROCEDURE: Biospecimen Collection — Undergo blood sample collection
- PROCEDURE: Bone Marrow Aspirate — Undergo bone marrow aspirate
- OTHER: Electronic Health Record Review — Medical records are reviewed
Primary Outcomes
- Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy (Baseline (at enrollment))
Full Eligibility Criteria
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 Locations
- Mayo Clinic in Arizona, Scottsdale, Arizona, United States
- Mayo Clinic in Florida, Jacksonville, Florida, United States
- Mayo Clinic in Rochester, Rochester, Minnesota, United States
Frequently Asked Questions
What is clinical trial NCT06279572?
NCT06279572 is a Not Applicable OBSERVATIONAL study titled "Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy." It is currently recruiting and is sponsored by Mayo Clinic. The trial targets enrollment of 80 participants.
What conditions does NCT06279572 study?
This trial investigates treatments for Acute Myeloid Leukemia. The primary condition under study is Acute Myeloid Leukemia.
What treatments are being tested in NCT06279572?
The interventions being studied include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspirate (PROCEDURE), Electronic Health Record Review (OTHER). Undergo blood sample collection
What does Not Applicable mean for NCT06279572?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06279572?
This trial is currently "Recruiting." It started on 2021-04-22. The estimated completion date is 2027-12-31.
Who is sponsoring NCT06279572?
NCT06279572 is sponsored by Mayo Clinic. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06279572?
The trial aims to enroll 80 participants. The trial is currently recruiting and accepting new participants.
How is NCT06279572 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06279572?
The primary outcome measures are: Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy (Baseline (at enrollment)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06279572 being conducted?
This trial is being conducted at 3 sites, including Scottsdale, Arizona; Jacksonville, Florida; Rochester, Minnesota (United States).
Where can I find official information about NCT06279572?
The official record for NCT06279572 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06279572. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06279572 testing in simple terms?
This study looks at how the immune system responds in patients with a specific type of leukemia (AML) when they receive a combination of two drugs: azacitidine and venetoclax. It is for adults over 18 years old who have been newly diagnosed with acute myeloid leukemia and are starting treatment with azacitidine and venetoclax.
Why is this trial significant?
This trial is important because it aims to understand how the immune system reacts to a common AML treatment, which could lead to new ways to boost the body's own defenses against cancer.
What are the potential risks of participating in NCT06279572?
Potential risks include discomfort or bruising from blood draws and bone marrow aspiration. Side effects are related to the known side effects of azacitidine and venetoclax, which your doctor will discuss with you. There is a risk that the study may not directly benefit your individual treatment, as it is primarily for research. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06279572?
Ask your doctor if this study is right for you and what the potential benefits and risks are. Participation involves routine procedures like blood draws and bone marrow aspiration, which will be explained by the study team. Your medical information will be reviewed to gather data on your treatment and immune response. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06279572 signal from an investment perspective?
This observational study provides insights into the immune landscape of AML patients treated with a standard combination therapy, potentially informing the development of future immunotherapies in a s This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing blood and bone marrow samples, and allowing researchers to review your medical records. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Acute Myeloid Leukemia Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.