KISS

title: A phase II study of dasatinib followed by imatinib in newly diagnosed, previously untreated patients with chronic phase CML

Kinase Inhibition with Sprycel Start‐up

Cancer type: Chronic Myeloid Leukaemia
Status: In set up
Brief description:

 

The KISS Study is a multicentre, open label, prospective, non-randomised study of treatment modification in response to maintenance of remission at 12 months in chronic myeloid leukaemia (CML) patients. Patients must be newly diagnosed with CML and will be recruited from haematology centres across New Zealand. The study investigates a new treatment plan using two drugs called tyrosine kinase inhibitors (TKIs) that we already know are very effective in this disorder. Both drugs are approved by Medsafe for treating CML patients in NZ.

The study aims to determine whether there is an advantage to starting people on the newer, more potent inhibitor (dasatanib) in order to achieve a faster remission and then to switch to the older drug (imatinib) in people who reached a safe level of remission within one year of treatment on the dasatanib. Patients’ level of response and side effects on each treatment will be carefully monitored for two years. The KISS Study is accompanied by two other optional sub-studies. These sub-studies are:-

1. An investigation into the effect of dasatanib on bone metabolism by the Bone Group at the University of Auckland

2. An investigation into predictive molecular signatures in the leukaemia cells at the Leukaemia and Blood Cancer Research Unit, also at the University of Auckland.

Sites: Auckland, Counties Manukau, Waikato, Christchurch, Dunedin
Lead Investigator: Professor Peter Browett
Contact: Lindsey Wylde (l.wylde@auckland.ac.nz)
Sponsor: University of Auckland
Funder: Leukaemia and Blood Foundation
ClinicalTrials.gov reference: TBC
Ethics number: 17/NTA/44
Publications: None currently