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

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 - CABL001A2001B

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051240084

Enrollment

Registered

2024-07-05

Start date

2022-12-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CML, Ph+ ALL

Interventions

Asciminib alone or in combination with imatinib

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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: - Asymptomatic pancreatitis - abnormal ECG - any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment

Design outcomes

Primary

Measure	Time frame
long term safety data (i.e. Serious Adverse Events (SAEs) and Adverse Events (AEs)) of asciminib treatment	—

Countries

Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Italy, Japan, Korea, Lebanon, Malaysia, Mexico, Netherlands, Oman, Poland, Portugal, Rumania, Russia, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactKyosuke Yamauchi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026