Asciminib Roll-over Study
An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment
ClinicalTrials.gov Identifier: NCT04877522
Novartis Reference Number: CABL001A2001B
Last Update: Jan 30, 2023
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
Key Inclusion Criteria:
Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment.
Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.
Key Exclusion Criteria:
Participant has been discontinued from parent study treatment.
Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
Participant's ongoing treatment is currently approved and reimbursed at country level.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
Applicable only for participants on bosutinib treatment that switch to asciminib treatment at enrollment:
any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment
Other protocol-defined Inclusion/Exclusion criteria may apply.