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
- Bratislava, SlovakiaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with Ph+ CML or Ph+ ALL who are already taking part in a Novartis asciminib study. Their doctor must think they would benefit from continuing treatment.
- Age
- From 7 Years to 100 Years
- Sex
- All sexes can join.
- Disease stage
- Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) or Ph+ acute lymphoblastic leukemia (ALL).
- Earlier treatment
- Must currently be receiving asciminib (alone or with imatinib, nilotinib or dasatinib), or imatinib, nilotinib or bosutinib alone, in a Novartis-sponsored study. Must have followed the rules of that study.
- Biomarker or test result
- Philadelphia chromosome positive (Ph+) disease.
Main reasons for not taking part
- Stopped treatment in the earlier study
- Unresolved side effects possibly linked to treatment in the earlier study
- Current treatment already approved and reimbursed in their country
- Pregnant or breastfeeding women
- Women able to have children who do not use highly effective birth control
Read by machine on 12 November 2026.
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 Slovakia
- University Hospital BratislavaBratislava, SlovakiaNot yet recruiting
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.