Response Post Tyrosine Kinase Inhibitor: Assesment of sensitivity and therapeutic response to next-line therapy in Chronic Myeloid Leukaemia (CML10).
Australasian Leukaemia and Lymphoma Group (ALLG)Licence & Rights
This dataset is currently under embargo. The dataset is expected to be available on approximately 30-Jun-2027. Data requests are being accepted, with the proviso that data will only be shared following the primary publication and all other restrictions being met.
Dataset description
This dataset contains individual participant data (IPD) from the CML10 study, which evaluates response following tyrosine kinase inhibitor (TKI) therapy and assesses sensitivity and therapeutic response to next-line treatments in patients with chronic myeloid leukaemia (CML). The dataset includes patient-level demographic and clinical information such as age, sex, disease phase, molecular markers, and baseline laboratory values. Treatment data include prior TKI exposure, subsequent therapies, and treatment duration. Outcome data include molecular response assessments, treatment response, progression outcomes, and adverse events. The study population comprises of adult patients with CML undergoing evaluation following TKI therapy. This dataset is suitable for secondary analyses including studies of treatment sequencing, resistance mechanisms, response kinetics, and optimisation of therapy in CML.Date Information
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12610000055000
Funding
Commercial sector/Industry, BristolMyersSquibb
Scientific enquiries
Professor Timothy Hughes
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.
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
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.
Can healthy volunteers participate?
No
Population
Sample Size 679
Min. age 0 No limit
Max. age 0 No limit
Sex Both males and females
Condition category Chronic Myeloid Leukaemia (CML)
Condition code Cancer
Intervention
Intervention code Not applicable
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
Comparison
Control group Active
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.
Outcomes
Outcome: 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: 6month data collection. 12month data review annually for five years.