ASCENDANCE - ASCiminib Evaluation in Newly diagnosed CML with Dasatinib to Augment response in Complex genomic Etiology (ACTRN12623001338651)

At the start of the trial, Patients will have genetic testing and all patients will then receive treatment with Asciminib monotherapy at 80mg daily for the first four weeks, while the genetic results are analysed. Patients are then split into high or standard risks groups based on their genetic results. Patients determined to be at standard risk will continue to receive 80mg daily Asciminib monotherapy while high risk patients will receive combination therapy of: 80mg of Asciminib daily and 50mg of Dasatinib daily. Overall treatment duration is upto 2 years.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Andrew Perkins

Key inclusion data

Inclusion: Newly diagnosed Philadelphia positive Chronic Myeloid Leukaemia in Chronic phase in patients 18 years or older; Eligible for a reimbursed treatment with dasatinib under the PBS complex; drug program in Australia, the Pharmac system in New Zealand or through other arrangements with regulatory and funding authorities (compassionate supply or hospital funded supply). Exclusion: Treatment with strong inducers of CYP3A4/5, CYP2C8 and CYP2C9; Serious medical or psychiatric illness likely to interfere with safety and efficacy monitoring or otherwise jeopardising the participant’s health within this clinical study; uncontrolled medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infections, acute or chronic renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol.