Using patient-derived mouse models to find drugs that make venetoclax plus azacitidine work better in AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational program collects blood and bone marrow from adults with AML who are starting venetoclax plus azacitidine and uses those samples to create patient-derived xenograft (PDX) mouse models. Researchers will test multiple candidate drug combinations alongside standard-of-care in the PDX avatars to identify combinations that better kill tumor cells with minimal harm to healthy blood cells. The study will compare how the mice respond to treatments with how the original patient responded, and promising combinations will be moved into a separate Phase I clinical trial platform. Samples will be collected over up to two years through altruistic donation to build a drug-testing platform aimed at guiding precision therapies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Canberra Health Services
  Canberra, Australian Capital Territory, Australia Recruiting
• Prince of Wales Hospital
  Sydney, New South Wales, Australia Recruiting
• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting
• Royal North Shore Hospital
  Sydney, New South Wales, Australia Not yet recruiting

Study contacts

• Principal investigator: John Pimanda, Professor — University of New South Wales
• Study coordinator: John Pimanda, Professor
• Email: cosmos.jcsmr@anu.edu.au
• Phone: +61 000000000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.