coiaward2010

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)

Indication and most important inclusion criteria

This study includes male or female patients who:

- are at least 18 years old
- have an Eastern Co-Operative 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

Short description of intervention

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.

Type of study

First line trial

Current status

Recruiting

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

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

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


 
   
 

EU e-Privacy Directive