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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06782971




Registration number
NCT06782971
Ethics application status
Date submitted
9/01/2025
Date registered
20/01/2025
Date last updated
20/01/2025

Titles & IDs
Public title
Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX
Scientific title
COSMOS-Avatar: Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX
Secondary ID [1] 0 0
24-M-003
Universal Trial Number (UTN)
Trial acronym
COSMOS-Avatar
Linked study record

Health condition
Health condition(s) or problem(s) studied:
AML - Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Endpoint - Generation of =20 adult AML PDX models with clinically annotated samples, including treatment regimen and clinical outcome
Timepoint [1] 0 0
From enrolment (i.e., C1D1 of Ven+AZA treatment) up to end of treatment or 52 weeks post C1D1 (whichever applies first)
Secondary outcome [1] 0 0
Secondary Endpoint - Frequency and phenotype of leukemic cells measured by flow cytometry in AML PDX models and primary donor samples before and after VEN+AZA treatment.
Timepoint [1] 0 0
From enrolment (i.e., C1D1 of Ven+AZA treatment) up to end of treatment or 52 weeks post C1D1 (whichever applies first)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2030
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 0 0
Canberra Health Services - Canberra
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
2065 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Government body
Name
Clinical Hub for Interventional Research (CHOIR)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Institute NSW
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of New South Wales
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australian National University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06782971
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Pimanda, Professor
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
John Pimanda, Professor
Address 0 0
Country 0 0
Phone 0 0
+61 000000000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06782971