The evaluation of combined sensitising and hypomethylating therapy outcomes in AML.The evaluation of combined sensitising and hypomethylating therapy outcomes in AML. A pre-clinical and clinical drug testing program for compounds that show synergy with hypomethylating agents.
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COSMOS

 

COSMOS-Avatar is an observational study to develop new ways to test promising new medications to treat acute myeloid leukemia (AML). 

                                                                                                       NCT06782971 | ANZCTR | ClinTrial Refer

COSMOS-Avatar Study

 

Project Status 
Open to recruitment

Indication

Acute Myeloid Leukaemia (AML)

Goal

Treatment options for patients with AML who are unfit or refractory to intensive chemotherapy, or who have relapsed after hematopoietic stem cell transplantation, remain limited. Hypomethylating agents (HMAs) are effective in prolonging survival, but they are often associated with adverse events, and their therapeutic effects are temporary. 

Patient-derived xenografts (PDX) models have emerged as a valuable tool for drug testing in cancer research. A PDX model is where a patients cancer cells are implanted into an immunodeficient mouse. This allows replication of the primary tumour and its environment in vivo, mimicking the disease progression and treatment responses of their corresponding donor with superior fidelity and predictive potential compared to current in vitro systems. 

The goal of this observational study is to develop new ways to test drug combinations to kill tumour cells in patients with AML. The main question it aims to answer is whether there are new ways to speed up discovery of better treatments for AML patients using PDX models and whether these mice show treatment responses similar to the individual patient from whom the cells were derived.

Method

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. 

There will be two eligible cohorts who can participate in the study:

  1. Individuals diagnosed with or suspected AML who are not planned for intensive chemotherapy and are commencing venetoclax + azacitidine therapy.
  2. Individuals who have relapsed following, or are refractory to, intensive chemotherapy or hematopoietic stem cell transplantation, commencing venetoclax + azacitidine therapy.

Tumour cells obtained over 2 years through altruistic donation for this research will be used to generate AML PDX mouse models that will be used to compare standard of care and multiple candidate therapies simultaneously. Promising drug combinations identified through this study will proceed to a dedicated independent Phase I clinical trial platform to accelerate drug discovery and development of AML therapies.

CHOIR manages operations of COSMOS-Avatar in collaboration with researchers from the Lowy Cancer Research Centre and the Children’s Cancer Institute at the University of New South Wales (UNSW) Sydney. This study is funded by the Cancer Institute NSW and is being conducted over 5 years at Prince of Wales, Westmead, Royal North Shore and The Canberra Hospitals. 

Contact

Senior Trial Manager

Nada Bechara

Email: cosmos.jcsmr@anu.edu.au