Asciminib Roll-over Study

Korábbi kezelés

• Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.

Laborértékek

• Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment:
  • Asymptomatic (grade 2) pancreatitis if not resolved within 28 days
  • QTcF\>480msec or inability to determine QTc interval
  • 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.

Egyéb

• 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.

• 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.