Long-term asciminib treatment for people with chronic myeloid leukemia
Tests asciminib long term in people with chronic myeloid leukemia who finished an earlier study.
Plain-language title generated from the registry record
Registry title: Asciminib Roll-over Study
Key facts
- Where
- Badalona, Barcelona, Bilbao, L'Hospitalet de Llobregat, Madrid, Santa Cruz de Tenerife, Santiago de Compostela, Sevilla, and Valencia, SpainSee the 12 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 7 and 100 years old?
- What type of cancer has the patient been diagnosed with?
- Is the patient pregnant or breastfeeding?
Source: NCT04877522, who can take part
Where in Spain
- Institut Catala d'OncologiaBadalona, SpainTaking people
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario BasurtoBilbao, SpainTaking people
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario de la PrincesaMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario Nuestra Señora de CandelariaSanta Cruz de Tenerife, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
- Hospital Universitario Virgen De La MacarenaSevilla, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT04877522EU 2023-507557-16-00
- Record updated
- 9 November 2026
- Original 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 treatmentRead full original descriptionShow less
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
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
Inclusion: 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: Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information; 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; 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.