Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000055000
Ethics application status
Approved
Date submitted
14/01/2010
Date registered
19/01/2010
Date last updated
17/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of sensitivity and therapeutic response to next-line therapy in Chronic Myeloid Leukaemia (CML)
Scientific title
Response Post Tyrosine Kinase Inhibitor: Assesment of sensitivity and therapeutic response to next-line therapy in Chronic Myeloid Leukaemia (CML).
Secondary ID [1] 1304 0
nil
Universal Trial Number (UTN)
Trial acronym
CML10 RESIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukaemia (CML) 256538 0
Condition category
Condition code
Cancer 256711 256711 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This an observational study, collecting data at regular intervals (6monthly) on subjects for five years. Observing current treatment, change in treatment and rationale for change
Intervention code [1] 255815 0
Not applicable
Comparator / control treatment
there is no treatment intervention prescribed, patient therapy is at the discretion of the treating physician and as such data collection on when patients cease or change therapy is being collected.
Control group
Active

Outcomes
Primary outcome [1] 257597 0
the range and frequency of next-line therapies. The clincian will complete data into the case report form and submit to trial coordinating centre.
Timepoint [1] 257597 0
6month data collection.
12month data review annually for five years.
Secondary outcome [1] 262864 0
progression free survival by routine blood tests performed as standard by the clinician
Timepoint [1] 262864 0
3 or 6 monthly depending on patient and clinician. it is an observational study, so these timepoints may change according to the treating clinician and patient.
Secondary outcome [2] 262916 0
overall survival, measured at visit to clinician.
Timepoint [2] 262916 0
at each clinician visit, 6monthly minimum.

Eligibility
Key inclusion criteria
Patients of any age
Currently recieving Tyrosine Kinase Inhibitor(TKI)
Patients with Philadelphia Positive or Breakpoint Cluster Region (BCR) V-abl Abelson murine leukaemia viral oncogene homolog1 (ABL) confirmed CML.
Patients in any phase of CML including those with relapsed CML following allogeneic stem cell transplantation
Patients who can provide written informed consent. Minors must have parental/legal guardian consent and assent where required
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If in the investigator's opinion the patient is unlikely candidate for follow-up information due to unavailability.
Previous enrolment to the same registry.

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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
8/06/2010
Date of last participant enrolment
Anticipated
Actual
30/11/2015
Date of last data collection
Anticipated
1/03/2020
Actual
Sample size
Target
1000
Accrual to date
Final
679
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8543 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 16640 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 2403 0
New Zealand
State/province [1] 2403 0

Funding & Sponsors
Funding source category [1] 256306 0
Commercial sector/Industry
Name [1] 256306 0
BristolMyersSquibb
Country [1] 256306 0
Australia
Funding source category [2] 256307 0
Commercial sector/Industry
Name [2] 256307 0
Novartis
Country [2] 256307 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group (ALLG)
Address
Level 2, 10 St Andrews Place
East Melbourne
Victoria 3002
Country
Australia
Secondary sponsor category [1] 251626 0
None
Name [1] 251626 0
nil
Address [1] 251626 0
nil
Country [1] 251626 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258389 0
Ethics committee address [1] 258389 0
Ethics committee country [1] 258389 0
Date submitted for ethics approval [1] 258389 0
01/02/2010
Approval date [1] 258389 0
27/05/2010
Ethics approval number [1] 258389 0

Summary
Brief summary
The target population for this study includes CML patients of any age residing in Australia or New Zealand with CML who have stopped TKI for any reason. Patients will be observed by there regular clinician and data submitted to the central trial coordinating centre.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 30699 0
Address 30699 0
Country 30699 0
Phone 30699 0
Fax 30699 0
Email 30699 0
Contact person for public queries
Name 13946 0
Bronwen Cox
Address 13946 0
CML10 Trial Coordinator
Level 3 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide South Australia 5000
Country 13946 0
Australia
Phone 13946 0
61882223375
Fax 13946 0
61882223368
Email 13946 0
bronwen.cox@health.sa.gov.au
Contact person for scientific queries
Name 4874 0
Professor Timothy Hughes
Address 4874 0
Principal Investigator CML10
South Australia Pathology
Frome Road
Adelaide
South Australia 5000
Country 4874 0
Australia
Phone 4874 0
61882223330
Fax 4874 0
61882223737
Email 4874 0
not available

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AISuccessful treatment-free remission in chronic myeloid leukaemia and its association with reduced immune suppressors and increased natural killer cells2020https://doi.org/10.1111/bjh.16718
N.B. These documents automatically identified may not have been verified by the study sponsor.