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

JRCT ID: jRCT2051240084

Registered date:05/07/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: CML, Ph+ ALL
• Date of first enrollment: 26/12/2022
• Target sample size: 4
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Italy,Japan,Korea,Japan,Lebanon,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,Oman,Japan,Poland,Japan,Portugal,Japan,Rumania,Japan,Russia,Japan,Saudi Arabia,Japan,Singapore,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Asciminib alone or in combination with imatinib

Outcome(s)

• Primary Outcome: long term safety data (i.e. Serious Adverse Events (SAEs) and Adverse Events (AEs)) of asciminib treatment

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Yamauchi Kyosuke
• Secondary ID(s): NCT04877522