Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000236493p
Ethics application status
Submitted, not yet approved
Date submitted
11/02/2025
Date registered
1/04/2025
Date last updated
1/04/2025
Date data sharing statement initially provided
1/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Chronic Myeloid Leukaemia: Treatment-Free Remission Registry
Scientific title
Chronic Myeloid Leukaemia: Treatment-Free Remission Registry
Secondary ID [1] 313810 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CML-TFR Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukaemia 336449 0
Condition category
Condition code
Blood 332969 332969 0 0
Haematological diseases
Cancer 333246 333246 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Participants with a diagnosis of Chronic Myeloid Leukaemia (CML) in chronic phase who have received Tyrosine Kinase Inhibitor (TKI) treatment and are planning a trial of TKI drug cessation with the objective of Treatment-Free Remission (TFR).

Screening Phase:
Participants will enter the Registry before they cease TKI treatment.
Retrospective data collected includes; demographics, CML diagnosis details, blood results at diagnosis, genetics results at diagnosis (if available), details of previous TFR attempts, CML treatment history and molecular response results data during the first 12 months of treatment after diagnosis.

Baseline Timepoint (2-4 weeks post screening):
Research blood sample collected and sent to SAHMRI Central Laboratory for processing, then participants will cease TKI the following day.
Retrospective data collected includes; molecular response data in the lead-up to TKI cessation, other therapies and percentage lymphocytes at time of TKI cessation, previously failed TKIs and kinase domain mutations (if detected).

Monitoring Phase:
Retrospective CML blood results as requested by the treating clinician will be recorded in the Registry at a frequency of every 3 months for up to 1 year, unless relapse occurs. Results to be reviewed and actioned by treating clinician as standard of care.

Follow-up Phase:
Restrospective data collected will include, survival status, TFR status including current CML disease phase will be recorded in the Registry at a frequency of every 3 months for up to 4 years, unless relapse occurs.

There will be a total of 5 years of the 'Monitoring' and 'Follow-up' phases combined, unless relapse/re-treatment occurs.

Relapse/Retreatment:
If retreatment with TKI occurs after a relapse of CML, participants will be followed for a further 1 year from commencing re-treatment. Including re-treatment details blood results as requested by the treating clinician indicating response to re-treatment.
Retrospective data collected will include; TKI commenced, any treatment switches in the first 12 months after retreatment and molecular response results after retreatment.
Intervention code [1] 330400 0
Diagnosis / Prognosis
Comparator / control treatment
'No control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340507 0
The proportion of participants discontinuing TKI (including STAMP inhibitors) who remain in TFR for a minimum of 12 months.
Timepoint [1] 340507 0
Screening, Baseline, Monitoring phase (1 year), Follow-up phase (4 years). Collecting observational data for total 5 years from TKI cessation. If TKI re-treatment during this time, 1 year of follow-up is completed after TKI re-start.
Secondary outcome [1] 444301 0
Nil
Timepoint [1] 444301 0
Nil

Eligibility
Key inclusion criteria
1. Adults (>18 years of age) who can provide written informed consent.

2. Diagnosis of chronic myeloid leukaemia, expressing BCR::ABL1 quantifiable by real-time PCR or digital PCR.

3. Completed a minimum of 3 years TKI therapy.
a. One or more previous TFR attempts are not an exclusion. Participants who have previously had a TFR attempt and re-started TKI treatment will still be eligible for the Registry if they have received at least 12 months of subsequent TKI treatment and meet all other inclusion criteria.

4. Currently, and for the preceding 12 months, maintaining MR4.0 response and receiving BCR::ABL1 TKI treatment over that period.

5. Intending to stop TKI treatment and not planning to resume CML treatment unless loss of MMR (i.e. BCR::ABL1 exceeds 0.1%).

6. Willing and able to provide blood samples for correlative sciences evaluation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of Philadelphia positive (Ph+) (or BCR::ABL1+) acute lymphoblastic leukaemia.

2. Current or prior blast crisis CML. Participants with prior accelerated phase (AP) may be enrolled at the discretion of the Investigator.

3. Prior allogeneic stem cell transplant for CML.

4. Life expectancy <2 years.

5. Unable or unwilling to comply with follow-up procedures.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/04/2025
Actual
Date of last participant enrolment
Anticipated
14/04/2028
Actual
Date of last data collection
Anticipated
14/04/2033
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318277 0
Charities/Societies/Foundations
Name [1] 318277 0
Leukaemia Foundation Australia
Country [1] 318277 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Research Institute (SAHMRI)
Address
Country
Australia
Secondary sponsor category [1] 320663 0
None
Name [1] 320663 0
Address [1] 320663 0
Country [1] 320663 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316919 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316919 0
Ethics committee country [1] 316919 0
Australia
Date submitted for ethics approval [1] 316919 0
18/03/2025
Approval date [1] 316919 0
Ethics approval number [1] 316919 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139426 0
A/Prof David Ross
Address 139426 0
Royal Adelaide Hospital, Port Road, ADELAIDE SA 5000
Country 139426 0
Australia
Phone 139426 0
+61 08 7074 2429
Fax 139426 0
Email 139426 0
[email protected]
Contact person for public queries
Name 139427 0
David Ross
Address 139427 0
Royal Adelaide Hospital, Port Road, ADELAIDE SA 5000
Country 139427 0
Australia
Phone 139427 0
+61 08 7074 2429
Fax 139427 0
Email 139427 0
[email protected]
Contact person for scientific queries
Name 139428 0
David Ross
Address 139428 0
Royal Adelaide Hospital, Port Road, ADELAIDE SA 5000
Country 139428 0
Australia
Phone 139428 0
+61 08 7074 2429
Fax 139428 0
Email 139428 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.