The goal of this observational study is to develop new ways to test new drug combinations to kill tumour cells, in patients with acute myeloid leukemia (AML). The main questions it aims to answer are:
* Are there new ways to speed up discovery of better treatments for AML patients using AML cells from individual from patients in special mice that can accept human tissue?
* Do these mice show treatment responses that are similar to the individual AML patient from whom cells were derived?
Participants with AML who are taking standard of care treatment of venetoclax and azacitidine will be asked to donate blood and bone marrow samples for this study.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age 18 years and above
2. Patients with suspicion of AML requiring screening procedures
3. Documented diagnosis of AML by WHO Classification and/or International Consensus Classification.
* Regardless of the number and type of prior lines of therapy or eligibility for allogeneic stem cell transplantation.
* All AML subtypes are eligible.
* Concurrent participation in clinical trials is allowed.
4. Documented myeloblast percentage ≥20% in the bone marrow or peripheral blood within 12 weeks of C1D1 confirmed by bone marrow aspirate or peripheral blood smear.
5. Planned to commence venetoclax and azacitidine therapy.
6. Provision of written informed consent prior to any study-related assessments or procedures being carried out.
Exclusion Criteria:
1\. Presence of any condition that, by assessment of the Investigator, would compromise the safety of the patient if they participated, the quality of trial data, or their adherence to the study-specified procedures.
Primary outcome measure(s)
Primary Endpoint - Generation of ≥20 adult AML PDX models with clinically annotated samples, including treatment regimen and clinical outcome — From enrolment (i.e., C1D1 of Ven+AZA treatment) up to end of treatment or 52 weeks post C1D1 (whichever applies first) The outcome measures are 1) establish an adult AML PDX drug testing platform; 2) determine how accurately the AML PDX model replicates the clonal architecture and cellular characteristics of the original tumour by comparing donors' samples to AML PDX samples; 3) compare efficacy of standard of care and candidate therapies by engrafting multiple immune-deficient mice with the same donor sample; and 4) biomarker discovery through correlation of treatment response and single-cell and cytokine analysis.
Trial sites (4)
Facility
City
Region
Status
Canberra Health Services
Canberra
Australian Capital Territory
Recruiting
Prince of Wales Hospital
Sydney
New South Wales
Recruiting
Royal North Shore Hospital
Sydney
New South Wales
Not Yet Recruiting
Westmead Hospital
Westmead
New South Wales
Recruiting
More Clinical Hub for Interventional Research (CHOIR) trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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