RecruitingNCT06782971

Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX

COSMOS-Avatar: Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX


Sponsor

Clinical Hub for Interventional Research (CHOIR)

Enrollment

25 participants

Start Date

Jun 6, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria9

  • Age 18 years and above
  • Patients with suspicion of AML requiring screening procedures
  • 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.
  • 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.
  • Planned to commence venetoclax and azacitidine therapy.
  • Provision of written informed consent prior to any study-related assessments or procedures being carried out.

Exclusion Criteria1

  • \. 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.

Locations(4)

Canberra Health Services

Canberra, Australian Capital Territory, Australia

Prince of Wales Hospital

Sydney, New South Wales, Australia

Royal North Shore Hospital

Sydney, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

View Full Details on ClinicalTrials.gov

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NCT06782971


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