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Clinical trials for Asciminib

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    9 result(s) found for: Asciminib. Displaying page 1 of 1.
    EudraCT Number: 2018-002256-33 Sponsor Protocol Number: FASCINATION Start Date*: 2019-11-14
    Sponsor Name:Friedrich-Schiller-Universität Jena
    Full Title: Frontline Asciminib combination in chronic phase CML
    Medical condition: Chronic Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10009700 CML LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001594-24 Sponsor Protocol Number: CABL001E2201 Start Date*: 2018-10-17
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase 2, multi-center, open-label, randomized study of oral asciminib added to imatinib versus continued imatinib versus switch to nilotinib in patients with CML-CP who have been previously treat...
    Medical condition: Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with imatinib and have not achieved deep molecular response
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) CZ (Trial now transitioned) ES (Ongoing) PT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) PL (Completed) DK (Completed) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-000678-27 Sponsor Protocol Number: CABL001J12301 Start Date*: 2021-08-10
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leuk...
    Medical condition: Chronic Myelogenous Leukemia in chronic phase (CML-CP) in newly diagnosed patients
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) HU (Trial now transitioned) DE (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) SK (Trial now transitioned) SE (Trial now transitioned) AT (Trial now transitioned) NO (Trial now transitioned) BE (Trial now transitioned) BG (Trial now transitioned) FI (Trial now transitioned) NL (Completed) DK (Trial now transitioned) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001286-20 Sponsor Protocol Number: CABL001I12201 Start Date*: 2021-07-29
    Sponsor Name:Novartis Pharma AG
    Full Title: A multi-center, open-label study to determine the dose and safety of oral asciminib in pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP...
    Medical condition: Pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with one or more tyrosine kinase inhibitors
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10054352 Chronic phase chronic myeloid leukemia LLT
    21.0 100000004864 10060498 Juvenile chronic myeloid leukemia LLT
    24.0 100000004864 10082178 Philadelphia positive chronic myeloid leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned) DE (Trial now transitioned) PL (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-000602-17 Sponsor Protocol Number: CABL001A2001B Start Date*: 2021-08-10
    Sponsor Name:Novartis Pharma AG
    Full 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 fr...
    Medical condition: CML-CP (at the end of parent study) who are currently participating in an asciminb Novartis sponsored study (parent study)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) CZ (Trial now transitioned) ES (Ongoing) DE (Ongoing) BG (Trial now transitioned) IT (Trial now transitioned) PT (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned) AT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000995-21 Sponsor Protocol Number: CABL001J12302 Start Date*: 2022-09-19
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic My...
    Medical condition: Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia in chronic phase (CML-CP) in newly diagnosed patients
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) HU (Trial now transitioned) SK (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned) NL (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-006057-21 Sponsor Protocol Number: CABL001A2302 Start Date*: 2021-09-17
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase 3b, multi-center, open-label, treatment optimization study of oral asciminib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP) previously treated with 2 or more tyrosi...
    Medical condition: Chronic Myelogenous Leukemia in chronic phase (CML-CP)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002461-66 Sponsor Protocol Number: CABL001A2301 Start Date*: 2017-10-09
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase 3, multi-center, open-label, randomized study of oral ABL001 versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyro...
    Medical condition: Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) ES (Ongoing) BG (Completed) DE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) NL (Completed) BE (Completed) IT (Completed) RO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000618-30 Sponsor Protocol Number: 11272 Start Date*: 2018-10-05
    Sponsor Name:GWT-TUD GmbH
    Full Title: Phase 2 Clinical Trial with Ponatinib as a Second Line Therapy for Patients with Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to prior First Line Tyrosine Kinase Inhibitor Trea...
    Medical condition: Adult patients (age ≥ 18) with Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) who have proven to be resistant or intolerant to prior first line Tyrosine Kinase Inhibitor Treatment
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10054352 Chronic phase chronic myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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