ClinTrial Refer

Trial Acronym
COSMOS-Avatar

Registration Number
NCT06782971

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

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.

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.

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.

Trial Location Name

Address

Status

Prince of Wales Hospital (Haematology)

Prince of Wales Hospital, Shop 8 Barker St, Randwick NSW 2031, Australia

Recruiting

Primary Contact : Karen McCardie, karen.mccardie@health.nsw.gov.au , 02 9382 5191

Clinical Hub for Interventional Research (CHOIR)

Website URL

Link Name

Link URL

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT06782971

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT06782971

Secondary IDs
24-M-003

Study Type
Observational

Intervention Code
Not applicable

Phase
Not Applicable

Minimum Age
18

Maximum Age
100

Date Registered
14/01/2025

Date Closed
N/A

Status
Open

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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