The Australasian RESIST (CML10) Study
Response Post Tyrosine Kinase Inhibitor: Assessment of Sensitivity and Therapeutic Response to Next-Line Therapy in CML.
The aims of the TKI registry are to: collect information about reasons for stopping Tyrosine Kinase Inhibitor (TKI) treatment, to determine the time to stopping TKI treatment and to determine overall survival and progression free survival of patients enrolled onto the TKI registry.
The aims of the STOP registry are to: determine the clinical status of patients changing to further treatment, to collect information about selection of further treatment, to collect information about overall survival and progression free survival of patients, to assess the association between patient disease and treatment response with reasons for stoping treatment, too assess the association between patient response and further treatment selected, to determine the rate and success of transplants, to determine the frequency and reasons for stopping treatment, to determining the rate and outcomes of pregnancy and to determine patients' response to further treatment.
In Australia and New Zealand, an estimated 70 chronic myeloid leukaemia (CML) will stop imatinib and start another therapy or observation each year. The reasons for stopping will include resistance to imatinib, worsening of CML, intolerance to imatinib, other illness and pregnancy. A smaller number will cease Tyrosine Kinase Inhibitor (TKI) treatment and move onto another treatment. The actual frequency of patients stopping TKI treatment, the type of further treatment selected and the outcome of further treatment have not been well studied.
This study will consist of two registries and a laboratory study. In order to determine the reasons for and frequency of stopping TKI treatment, a TKI registry of patients with CML on TKI treatment will be set up. The STOP registry will aim to capture data on all consenting patients in Australia and New Zealand who switch or stop their current TKI. All patients on the STOP registry will have regular blood analysis of PCR and mutation done in order to characterise the range of mutations that occur with TKI treatment. Patients who are not pre-registered on the TKI registry will still be eligible for the STOP registry and Correlative studies. The Correlative studies will investigate other tests designed to better predict patient's response to further treatment.