Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Bcr-abl tyrosine-kinase inhibitors

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   44336   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    26 result(s) found for: Bcr-abl tyrosine-kinase inhibitors. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2006-002011-27 Sponsor Protocol Number: CLBH589B2211 Start Date*: 2007-01-24
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase II, multicentre study of oral LBH589 in patients with accelerated phase or blast phase (blast crisis) chronic myeloid leukemia with resistant disease following treatment with at least two B...
    Medical condition: Patients with accelerated phase (AP) or blast crisis (BC) CML who have disease-resistance following treatment with at least two BCR-ABL tyrosine kinase inhibitors (i.e., imatinib, nilotinib, or das...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10009015 Chronic myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DK (Completed) FR (Prematurely Ended) DE (Completed) NL (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-006962-41 Sponsor Protocol Number: CSTI571ADE60 Start Date*: 2008-03-27
    Sponsor Name:Charité Universitätsmedizin Berlin
    Full Title: Dendritic cells as autologous vaccine in patients with chronic myeloid leukemia
    Medical condition: Chronic myeloid leukemia is a malignant disease of the blood. Without therapy it has an unfavourable prognosis. Under first-line therapy with newer inhibitors of the thymidinkinase some few patien...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-000881-35 Sponsor Protocol Number: CLBH589B2202 Start Date*: 2007-01-11
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase II, multicentre study of oral LBH589 in patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
    Medical condition: Adult patients with chronic phase Ph+ CML whose disease is resistant following treatment with at least two BCR-ABL tyrosine kinase inhibitors (i.e. imitinib, nilotinib, or dasatinib).
    Disease: Version SOC Term Classification Code Term Level
    8.1 10009015 Chronic myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) BE (Completed) NL (Completed) FR (Completed) GB (Prematurely Ended) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-005208-26 Sponsor Protocol Number: P13/12 Start Date*: 2016-02-22
    Sponsor Name:Centre Hospitalier de Versailles
    Full Title: CANDIDATE THERAPIES IN COMBINATION OR SEQUENTIALLY WITH TYROSINE KINASE INHIBITORS IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN COMPLETE CYTOGENETIC RESPONSE WITHOUT ACHIEVIN...
    Medical condition: CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10058246 Chronic myelogenous leukaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-004384-19 Sponsor Protocol Number: GIMEMA CML0408 Start Date*: 2008-07-29
    Sponsor Name:G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
    Full Title: Front-line treatment of Philadelphia positive (Ph pos), BCR-ABL positive, chronic myeloid leukemia (CML) with two tyrosine kinase inhibitors (TKI) (Nilotinib and Imatinib). A phase II exploratory m...
    Medical condition: Philadelphia positive (Ph pos), BCR-ABL positive, Chronic Myeloid Leukemia (CML)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009013 Chronic myeloid leukaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-013271-22 Sponsor Protocol Number: GIMEMA LAL1408 Start Date*: 2009-11-09
    Sponsor Name:G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO
    Full Title: Front-line treatment of Ph positive (Ph+)/Bcr-Abl positive Acute Lymphoblastic Leukemia (ALL) with two tyrosine kinase inhibitors (TKI) (Imatinib and Nilotinib). A phase II exploratory multicentr...
    Medical condition: Ph positive (Ph+)/Bcr-Abl positive Acute Lymphoblastic Leukemia (ALL)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000844 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    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: 2013-004323-37 Sponsor Protocol Number: BOS-IIG-01 Start Date*: 2015-03-24
    Sponsor Name:Fundación PETHEMA para el tratamiento de la leucemia y el linfoma
    Full Title: Single nucleotide polymorphism association with response and toxic effects in patients with Ph+ CP-CML treated with bosutinib after relapse or intolerance to previous treatment.
    Medical condition: Patients with chromosome Philadelphia positive (Ph+) in chronic phase mielogenus leukemia (CP CML)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10022891 - Investigations 10034877 Philadelphia chromosome positive PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-004950-25 Sponsor Protocol Number: D-00272-CT2014001 Start Date*: 2008-01-06
    Sponsor Name:Cell Medica Ltd
    Full Title: WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study
    Medical condition: Acute Myeloid Leukaemia and Chronic Myeloid Leukaemia in adults.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009013 Chronic myeloid leukaemia PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-006581-20 Sponsor Protocol Number: HEMCML28 Start Date*: 2022-05-11
    Sponsor Name:Radboud univeristy medical centre
    Full Title: A patient guided dose reduction strategy of tyrosine kinase inhibitors in chronic myeloid leukaemia: a prospective, multi-centre, non-randomised non-inferiority study.
    Medical condition: Chronic myeloid leukaemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10024296 Leukaemias chronic myeloid HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-003389-42 Sponsor Protocol Number: DASA-PEGIFN Start Date*: 2013-06-26
    Sponsor Name:CHU DE POITIERS
    Full Title: A phase II study to assess the efficacy and safety of frontline combination of dasatinib (SPRYCEL®) and pegylated-interferon alpha 2b (Peg-IFNα2b) therapy in patients newly diagnosed with chronic p...
    Medical condition: Patients with newly diagnosed chronic phase Chronic Myeloid Leukemia (CP-CML), not previously treated with Tyrosine Kinase Inhibitors (TKIs). First line therapy.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10054352 Chronic phase chronic myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    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: 2007-001286-15 Sponsor Protocol Number: CGX-635-CML-203 Start Date*: 2007-09-05
    Sponsor Name:Stragen France
    Full Title: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) who have failed or are intolerant to t...
    Medical condition: Chronic Myeloid Leukaemia (CML)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10009015 Chronic myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) FR (Completed) GB (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001617-12 Sponsor Protocol Number: AP24534-14-203 Start Date*: 2017-10-09
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses
    Medical condition: Chronic Phase Chronic Myeloid Leukemia
    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: SE (Completed) CZ (Completed) DE (Completed) FI (Prematurely Ended) ES (Completed) DK (Completed) NO (Completed) BE (Completed) FR (Trial now transitioned) NL (Completed) PT (Completed) PL (Trial now transitioned) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-004165-20 Sponsor Protocol Number: AITIK Start Date*: 2023-04-26
    Sponsor Name:CHU de Poitiers
    Full Title: Discontinuation of Tyrosine Kinase Inhibitors in chronic myeloid leukemia and impact on the immune system: a randomized controlled trial of two therapeutic strategies
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10009015 Chronic myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-003250-25 Sponsor Protocol Number: B1871039 Start Date*: 2014-06-24
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: A Phase 4 Safety and Efficacy Study of Bosutinib (Bosulif®) in Patients with Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated with One or More Tyrosine Kinase Inhibitors
    Medical condition: Philadelphia Chromosome Positive Chronic Myeloid Leukaemia
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009013 Chronic myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed) DE (Prematurely Ended) IT (Completed) BE (Completed) NL (Completed) ES (Completed) AT (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2015-004998-33 Sponsor Protocol Number: CAMN107ADE22T Start Date*: 2016-06-24
    Sponsor Name:University of Heidelberg
    Full Title: Multicenter prospective trial after first or second unsuccessful treatment discontinuation in chronic myeloid leukemia estimating the efficacy of nilotinib in inducing the persistence of molecular ...
    Medical condition: CML-Patients in chronic phase having failed a prior attempt to stop imatinib or other TKIs therapy either within EURO-SKI or not and are pretreated at least one year with any TKI after 1st stop
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Completed)
    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: 2016-002216-40 Sponsor Protocol Number: CML1516 Start Date*: 2016-10-04
    Sponsor Name:FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
    Full Title: BOSUTINIB EFFICACY SAFETY TOLERABILITY (BEST) STUDY IN ELDERLY CHRONIC MYELOID LEUKEMIA PATIENTS FAILING FRONT-LINE TREATMENT WITH OTHER TYROSINE KINASE INHIBITORS
    Medical condition: Chronic Myeloid Leukemia (CML) in Chronic Phase
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009013 Chronic myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-000440-22 Sponsor Protocol Number: EURO-SKI01 Start Date*: 2012-04-11
    Sponsor Name:University of Heidelberg
    Full Title: MULTICENTER TRIAL ESTIMATING THE PERSISTANCE OF MOLECULAR REMISSION IN CHRONIC MYELOID LEUKAEMIA AFTER STOPPING TKI
    Medical condition: Patients with chronic myeloid leukemia with complete molecular response can stop tyrosine kinase inhibitors under close monitoring
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10009016 Chronic myeloid leukemia in remission LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing) FI (Completed) CZ (Completed) NL (Ongoing) NO (Completed) PT (Completed) AT (Prematurely Ended) ES (Ongoing) DK (Completed)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 19 16:05:34 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA