Study Description
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 This is an open-label, multi-center, global roll-over study designed to assess long term
safety and provide continued treatment to participants who have previously participated
in an asciminib Novartis sponsored study and who, in the opinion of the investigator,
would benefit from continued treatment as in their parent study but are unable to access
this treatment outside of the clinical study.
Interventions
Asciminib single agent
Bosutinib
Dasatinib
Imatinib
Nilotinib
Eligibility Criteria
Key Inclusion Criteria:
1. 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.
2. 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:
1. Participant has been discontinued from parent study treatment.
2. Participant currently has unresolved toxicities reported as possibly related to
study treatment in the parent study.
3. Participant's ongoing treatment is currently approved and reimbursed at country
level.
4. Pregnant or nursing (lactating) women.
5. Women of child-bearing potential, unless they are using highly effective methods of
contraception and willing to continue while taking study treatment.
6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib
unwilling to follow the relevant contraception requirements in the local prescribing
information.
7. 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.
Worldwide Contacts
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