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

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
Canberra Health Services
NOT_YET_RECRUITING
Canberra
Prince of Wales Hospital
RECRUITING
Sydney
Royal North Shore Hospital
NOT_YET_RECRUITING
Sydney
Westmead Hospital
NOT_YET_RECRUITING
Westmead
Contact Information
Primary
John Pimanda, Professor
cosmos.jcsmr@anu.edu.au
+61 000000000
Backup
Mark Polizzotto, Professor
cosmos.jcsmr@anu.edu.au
Time Frame
Start Date: 2025-06-06
Estimated Completion Date: 2030-03
Participants
Target number of participants: 25
Treatments
Cohort 1
Individuals diagnosed with or suspected of acute myeloid leukemia (AML) who are not planned for intensive chemotherapy and are commencing venetoclax + azacitidine therapy.
Cohort 2
Individuals who have relapsed following, or are refractory to, intensive chemotherapy or hematopoietic stem cell transplantation, commencing venetoclax + azacitidine therapy.
Related Therapeutic Areas
Sponsors
Leads: Clinical Hub for Interventional Research (CHOIR)
Collaborators: The University of New South Wales, Australian National University, Cancer Institute NSW

This content was sourced from clinicaltrials.gov

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