Actively Recruiting
COSMOS-Avatar: Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX
Led by Clinical Hub for Interventional Research (CHOIR) · Updated on 2025-12-08
25
Participants Needed
4
Research Sites
108 weeks
Total Duration
On this page
Sponsors
C
Clinical Hub for Interventional Research (CHOIR)
Lead Sponsor
C
Cancer Institute NSW
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating new ways to test drug combinations aimed at killing tumor cells in patients with acute myeloid leukemia (AML). This observational study focuses on whether using AML cells from individual patients in special mice that can accept human tissue can speed up the discovery of better treatments. It also evaluates if these mice show treatment responses similar to the actual AML patients from whom the cells were taken. Participants in this study are individuals with AML who are receiving the standard treatment of venetoclax and azacitidine. Blood and bone marrow samples will be collected from these patients to create patient-derived xenografts (PDX) in mice. These mice models mimic the patient's disease and treatment response, allowing researchers to test standard and multiple experimental therapies simultaneously over a period of up to two years. The study aims to generate at least 20 adult AML PDX models linked with detailed clinical data. During the study, participants will provide samples before and after starting venetoclax plus azacitidine therapy. Researchers will measure leukemic cell frequency and characteristics using flow cytometry in both the mouse models and patient samples. The main outcomes include the successful creation of AML PDX models and the evaluation of their treatment responses over up to 52 weeks. This approach supports precision therapies tailored to specific tumor profiles and may accelerate future clinical trials of promising drug combinations.
CONDITIONS
Brief Title
Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and above
- Patients with suspicion of AML requiring screening procedures
- Documented diagnosis of AML by WHO or International Consensus Classification
- Includes all AML subtypes regardless of prior therapies or transplant eligibility
- Myeloblast percentage 20% or more in bone marrow or peripheral blood within 12 weeks of treatment start
- Planned to begin venetoclax and azacitidine therapy
- Provided written informed consent before study procedures
You will not qualify if you...
- Any condition assessed by the investigator that would compromise patient safety, study data quality, or adherence to study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks from start of venetoclax and azacitidine treatment
Participants who undergo routine venetoclax and azacitidine therapy are observed for treatment outcomes and disease progression.
Regular visits as part of routine care
Trial Site Locations
Total: 4 locations
1
Canberra Health Services
Canberra, Australian Capital Territory, Australia, 2605
Actively Recruiting
2
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
Actively Recruiting
3
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Not Yet Recruiting
4
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
Research Team
J
John Pimanda, Professor
M
Mark Polizzotto, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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