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Taking people in ItalyPhase 4

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.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Genoa, Meldola, Milan, Pisa, Rome, and Turin, ItalySee the 7 sitesAlso in 31 other countries, 123 sites
Registry title
Asciminib Roll-over Study
Status
Recruiting
Phase
Phase 4
People taking part
347 people, planned
Started
30 Aug 2022
Expected to end
30 Aug 2030
Type of study
Interventional, 11 groups
Treatments tested
  • Asciminib single agent
  • Imatinib
  • Nilotinib
  • Bosutinib
  • Dasatinib
  • Asciminib single agent pediatric formulation
Record updated
9 November 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Italy

Also in 31 other countries, 123 sites

  • IRCCS Istituto Giannina GasliniGenoa, ItalyTaking people
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
  • ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
  • Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
  • Azienda Sanitaria Locale Roma 2Rome, ItalyTaking people
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people

About the trial

What the trial wants to find out

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

The 11 groups in the trial

  • Asciminib single agent groupTreatment being tested

    Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to CABL001A2301, CABL001A2302, CABL001X2101, CABL001A2202, CABL001AUS04 and CABL001AUS08 studies, that were receiving asciminib

    Treatment: Asciminib single agent

  • Bosutinib single agent groupOther group

    Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib

    Treatment: Bosutinib

  • Bosutinib-Asciminib switch groupTreatment being tested

    Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study

    Treatment: Asciminib single agent

  • Asciminib in combination with imatinib groupTreatment being tested

    Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib

    Treatment: Imatinib

  • Asciminib in combination with nilotinib groupTreatment being tested

    Participants with CML or ALL from Novartis sponsored asciminib studies CABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib

    Treatment: Nilotinib

  • Imatinib single agent groupOther group

    Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib

    Treatment: Imatinib

  • Nilotinib single agent groupOther group

    Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib

    Treatment: Nilotinib

  • Asciminib in combination with dasatinib groupTreatment being tested

    Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib

    Treatment: Dasatinib

  • Dasatinib single agent groupOther group

    Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.

    Treatment: Dasatinib

  • Dasatinib-Asciminib switch groupTreatment being tested

    Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2202 that were receiving best available therapy (dasatinib) and switched to asciminib when entering this study or during the course of this study

    Treatment: Asciminib single agent

  • Asciminib single agent formulation for PediatricTreatment being tested

    Participants with CML, from Novartis sponsored asciminib studies, including but not limited to CABL001I12201 study, that were receiving asciminib

    Treatment: Asciminib single agent pediatric formulation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Long-term asciminib treatment for people with chronic myeloid leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04877522, who can take part
Record updated
9 November 2026