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Trial Title:
Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy
NCT ID:
NCT06279572
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Observational (blood collection, bone marrow aspirate)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Marrow Aspirate
Description:
Undergo bone marrow aspirate
Arm group label:
Observational (blood collection, bone marrow aspirate)
Other name:
BONE MARROW, LIQUID
Other name:
Human Bone Marrow Aspirate
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Medical records are reviewed
Arm group label:
Observational (blood collection, bone marrow aspirate)
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Patients with acute myeloid leukemia who received azacitidine plus venetoclax
chemotherapy.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Cecilia Y. Arana Yi, M.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Talha Badar, M.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Mithun V. Shah, M.D., Ph.D.
Email:
Principal Investigator
Start date:
April 22, 2021
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06279572
https://www.mayo.edu/research/clinical-trials
