At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Asciminib single agent (drug), Imatinib (drug), Nilotinib (drug), Bosutinib (drug)
- How long the study runs
- Study runs about 96 months (dates as stated)
- About the drug or intervention
- Asciminib single agent — drug: Taken orally, twice daily (BID) or once daily (QD), in fasting state · Imatinib — drug: Taken orally, once daily, in the morning with low-fat meal · Nilotinib — drug: Taken orally, twice daily, on an empty stomach · Bosutinib — drug: Taken orally, once daily, with food · Dasatinib — drug: Taken orally, once daily in a fasted state, 1 or 2 hours before a meal · Asciminib single agent pediatric formulation — drug: Pediatric participants receive a body weight adjusted dose of 1.3 mg/kg of pediatric film coated granules with food twice daily (b.i.d.) or 2.6 mg/kg once daily (q.d.) in the morning.
- Patient visit burden
- Not specified by the sponsor
In plain English
This is a 'roll-over' study run by Novartis Pharmaceuticals for people with Philadelphia chromosome-positive chronic myelogenous leukaemia (a blood cancer) or Philadelphia chromosome-positive acute lymphoblastic leukaemia. It is for people who were already taking the study medicines, including asciminib, in an earlier Novartis study and whose doctor thinks they would benefit from continuing treatment.
Who can take part
- You are currently being treated with asciminib (on its own or with imatinib, nilotinib or dasatinib), or with imatinib, nilotinib or bosutinib alone, as part of a Novartis study.
- Your doctor believes you would benefit from continuing this treatment.
- You followed the rules of the earlier study and are willing and able to keep attending visits, follow the treatment plan and other study procedures.
Who may not be able to
- You stopped the treatment in the earlier study.
- You still have side effects from the earlier study treatment that have not gone away.
- Your current treatment is already approved and paid for in your country.
- You are pregnant or breastfeeding.
- You are a woman who could become pregnant and are not using highly effective contraception, or are unwilling to keep using it during the study.
- You are a sexually active man taking imatinib, nilotinib, bosutinib or dasatinib and are unwilling to follow the contraception rules in the local medicine information.
- For certain people switching to asciminib: pancreatitis (with no symptoms) that has not gone away within 28 days, a specific heart rhythm measure (QTcF) over 480 milliseconds or one that cannot be measured, or any severe side effect (grade 3 or 4) that has not improved to grade 2 or lower within 28 days.
What taking part involves
- • Continuing treatment with asciminib (on its own or with imatinib, nilotinib or dasatinib), or with imatinib, nilotinib or bosutinib alone.
- • Attending scheduled study visits and following the treatment plan and study procedures.
Time commitment: The length of the study and how often visits happen are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 7 Years to 100 Years
- Who
- All
- Number of participants
- 347
- Started
- 2022-08-30
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for chronic myelogenous leukemia
- • Phase4 - 347 participants
- • 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 take part?
- • Ages 7 Years to 100 Years
- • Diagnosed with chronic myelogenous leukemia
Where?
- • London - Novartis Investigative Site
- • Oxford - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
More detail
This is an open-label, multi-center, global roll-over study designed to assess long term safety and provide continued treatment to participants who have previously participated in an asciminib Novartis sponsored study and who, in the opinion of the investigator, would benefit from continued treatment as in their parent study but are unable to access this treatment outside of the clinical study.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 7 Years - 100 Years
- Who can join: All genders
What the study is looking for
- ✓Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with...
Who cannot take part
- ✗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...
See the full criteria
Where Is This Study? (2 UK sites)
Novartis Investigative Site
London W12 0HS, United Kingdom
Novartis Investigative Site
Oxford OX3 7LE, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT