KISS = Kinase Inhibition With Sprycel Start up [New Zealand]
Study title
KISS: Kinase Inhibition With Sprycel Start up
Scientific title
KISS Study: A Phase II Study of Dasatinib Followed by Imatinib in Newly Diagnosed, Previously Untreated Patients With Chronic Phase CML (ClinicalTrials.gov NCT03193281)
Type of study
Trials that are no longer recruiting
Phase
Current status
No longer recruiting
Other trial ID
CTNZ-2012-08
What is the purpose of the study
This study will assess the efficacy and safety of a treatment plan for patients with newly diagnosed CML-CP. In the first study stage, patients will be given dasatinib (Sprycel) to more rapidly induce a molecular response (MR3.0). At 13 months, patients will be switched to imatinib to maintain CML in that remission.
Patients who do not achieve confirmed MR3.0 at 13 months will not be eligible to switch to imatinib treatment and will continue on dasatinib treatment.
Key inclusion criteria
This study includes male or female patients who:
– are at least 18 years old
– have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
– have been diagnosed with chronic myeloid leukemia in chronic phase within 3 months of enrolment
– have cytogenetic or molecular confirmation of Philadelphia chromosome (Ph+) or variants of (9;22) translocations
Key exclusion criteria
Estimated primary completion date
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study sponsor
University of Auckland, New Zealand, in collaboration with Leukaemia & Blood Cancer, New Zealand
Scientific lead / contact
Professor Peter Browett, University of Auckland, New Zealand
Principal investigator
Professor Peter Browett, University of Auckland, New Zealand
Study centers / principal investigators
New Zealand
Auckland City Hospital
Auckland
Principal Investigator: Prof Peter Browett
Middlemore Hospital
Auckland
Principal Investigator: Dr Gordon Royle
Christchurch Hospital
Christchurch
Principal Investigator: Dr Emma Jane McDonald
Dunedin Hospital
Dunedin
Principal Investigator: Dr Lucy Pemberton
Waikato Hospital
Hamilton
Principal Investigator: Humphrey Pullon
Taranaki Base Hospital
New Plymouth
Principal Investigator: Bart Baker
Palmerston North Hospital
Palmerston North
Principal Investigator: Bart Baker
North Shore Hospital
Takapuna
Principal Investigator: Henry Chan
Wellington Hospital
Wellington
Principal Investigator: Victoria Campion