Asciminib Roll-over Study (NCT04877522) | Clinical Trial Compass
RecruitingPhase 4
Asciminib Roll-over Study
United States, Argentina, Austria347 participantsStarted 2022-08-30
Plain-language summary
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
Who can participate
Age range
7 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a roll-over study, does that mean I would need to have already been in a previous asciminib trial to even be considered for this one, and if so, does that apply to my situation?
2This trial is in Phase 4 and is primarily tracking side effects and serious adverse events — what does that tell us about how much is already known about asciminib's safety, and are there any side effects from earlier studies that I should be specifically aware of?
3Because the main thing being measured here is adverse events rather than whether the drug is working better than alternatives, would continuing in this roll-over study give me access to asciminib in a way that's different from what's already approved or available to me outside a trial?
4How does asciminib compare to the standard TKI treatments I might otherwise be on for BCR-ABL positive CML, and is there a reason my doctor thinks staying on asciminib through this roll-over study would be a better path than switching to a standard option?
5What would the practical demands of this trial look like for my day-to-day life — how often would I need to come in for visits or monitoring, and is that realistic given my current situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
. Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment: