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Clinical trials for CML AND Imatinib Mesylate AND Imatinib

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
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    • 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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    17 result(s) found for: CML AND Imatinib Mesylate AND Imatinib. Displaying page 1 of 1.
    EudraCT Number: 2010-019568-35 Sponsor Protocol Number: OPTIM IMATINIB Start Date*: 2010-06-14
    Sponsor Name:CH VERSAILLES
    Full Title: A prospective randomized phase II study evaluating the monitoring of imatinib mesylate (Gliveec®) plasmatic through level in patients newly diagnosed with chronic phase chronic myelogenous leukaemi...
    Medical condition: Chronic Phase Chronic myelogenous leukemia (CP CML)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-002601-69 Sponsor Protocol Number: CA180-013 Start Date*: 2005-01-25
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: A Phase II Study to Determine the Activity of BMS-354825 in Subjects with Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease that is Resistant to High Dose Ima...
    Medical condition: Chronic phase Philadelphia chromosome-positive chronic myeloid leukemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) SE (Completed) FI (Completed) GB (Completed) IE (Completed) IT (Completed) BE (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2005-001169-32 Sponsor Protocol Number: CA180-035 Start Date*: 2005-11-16
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects with Chronic Myeloid Leukemia in Acce...
    Medical condition: Subjects with Chronic Myeloid Leukemia (CML) in Accelerated Phase (AP) or in Myeloid (My) or Lymphoid (Ly) Blast Phase (BP) or with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) HU (Completed) DK (Completed) IE (Completed) CZ (Completed) FI (Completed) ES (Completed) IT (Completed) BE (Completed) DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-011675-79 Sponsor Protocol Number: ACTIM Start Date*: 2009-07-10
    Sponsor Name:CH-Versailles
    Full Title: A PHASE II STUDY TO ASSESS EFFICACY AND SAFETY OF PIOGLITAZONE (ACTOS®) AS ADD-ON THERAPY TO IMATINIB MESYLATE (GLEEVEC®) IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN MAJOR...
    Medical condition: chronic phase chronic myelogenous leukaemia (CP-CML) patients in major molecular response.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-001294-99 Sponsor Protocol Number: CA180-034 Start Date*: 2005-07-18
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects with Chronic Ph...
    Medical condition: Subjects with Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia who are resistant or intolerant to Imatinib Mesylate
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SE (Completed) GB (Completed) HU (Completed) DK (Completed) IE (Completed) CZ (Completed) FI (Completed) IT (Completed) EE (Completed) ES (Completed) DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-007094-20 Sponsor Protocol Number: IB 2009-07 Start Date*: 2009-07-17
    Sponsor Name:Institut Bergonié
    Full Title: Étude multicentrique de phase III évaluant L’efficacité d’une stratégie d’adaptation de dose de l’imatinib mésylate sur la réponse moléculaire chez des patients présentant une leucémie myéloïde chr...
    Medical condition: Patients présentant une leucémie myéloïde chronique en phase chronique (LMCPC) traités par IM depuis au moins 2 ans, en réponse cytogénétique complète depuis au moins 1 an, avec une maladie résidue...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009015 Chronic myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-002517-36 Sponsor Protocol Number: CA180-015 Start Date*: 2004-12-27
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: A Phase II Study of BMS-354825 in Subjects with Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib...
    Medical condition: Lympohid blast phase chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (ALL)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Completed) FI (Completed) GB (Completed) DK (Completed) IT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-000881-10 Sponsor Protocol Number: CSTI571AAT06 Start Date*: 2005-03-08
    Sponsor Name:CELSG (Central European Leukemia Study Group)
    Full Title: International, multicenter, randomised, open-labeled, 2-arm - Phase III Study comparing Imatinib (STI571, Glivec®) Standard Dose (400 mg/day) with Imatinib High Dose Induction (800 mg/day) followed...
    Medical condition: patients with chronic myelogenous leukemia in chronic phase (Ph+/BCR-ABL+)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-002516-28 Sponsor Protocol Number: CA180-006 Start Date*: 2004-12-27
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: A Phase II Study of BMS-354825 in Subjects with Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate Revised Protocol 01: Incorporates Amendment 03 and Admi...
    Medical condition: Myeloid Blast Phase Chronic Myeloid Leukemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Completed) FI (Completed) GB (Completed) DK (Completed) IT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2004-004450-96 Sponsor Protocol Number: CA180-017 Start Date*: 2005-01-25
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: A Randomized Multi-center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects with Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have D...
    Medical condition: Chronic phase Philadelphia-Chromosome Positive (Ph+) Chronic Myeloid leukemia (CML)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SE (Completed) DE (Completed) HU (Completed) FI (Completed) GB (Completed) IE (Completed) DK (Completed) EE (Completed) ES (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2004-002515-89 Sponsor Protocol Number: CA180-005 Start Date*: 2004-12-27
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: A Phase II Study of BMS-354825 in Subjects with Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate Revised Protocol 01: Incorporates Amendment 03 and Admini...
    Medical condition: Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Completed) FI (Completed) GB (Completed) IT (Completed) DE (Completed) BE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2005-000813-36 Sponsor Protocol Number: HHT-CML/INTL/04.2 Start Date*: 2005-10-14
    Sponsor Name:STRAGEN France [...]
    1. STRAGEN France
    2. ChemGenex Pharmaceuticals Ltd.
    Full Title: A phase II, multicentre, single-arm, open-label study of subcutaneous homoharringtonine (HHT) alone in patients with accelerated phase chronic myeloid leukemia (CML) who are refractory to, or have ...
    Medical condition: Accelerated phase Chronic Myeloid Leukaemia (CML).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-001804-31 Sponsor Protocol Number: CSTI571AJP02 Start Date*: 2017-08-10
    Sponsor Name:Novartis Pharma K.K
    Full Title: Ph3 trial of Glivec in CML-CP patients previously untreated with IFN-alfa
    Medical condition: CML-CP patients
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005248-33 Sponsor Protocol Number: CML1415 Start Date*: 2018-06-21
    Sponsor Name:Fondazione GIMEMA Franco Mandelli ONLUS
    Full Title: SUSTRENIM Study – GIMEMA CML1415 Sustained treatment-free remission in BCR-ABL+ chronic myeloid leukemia: a prospective study comparing Nilotinib versus Imatinib with switch to Nilotinib in absence...
    Medical condition: Chronic myeloid leukemia (CML) in chronic phase (CP)
    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: NL (Trial now transitioned) BE (Completed) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-018418-53 Sponsor Protocol Number: CSTI571A2110 Start Date*: 2010-06-01
    Sponsor Name:Novartis Pharma Service AG
    Full Title: A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia...
    Medical condition: Chronic Myeloid Leukemia (CML) and Philadelphia chromosome positive Acute Lymphoblastic Leukemia (Ph+ ALL)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10009015 Chronic myeloid leukemia LLT
    12.1 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) NL (Prematurely Ended) HU (Completed) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-004106-13 Sponsor Protocol Number: NORDCML006 Start Date*: 2009-03-23
    Sponsor Name:University of Trondheim, NTNU, Norway
    Full Title: An Open-Label, Randomized, Multicenter Phase II Trial Comparing the Depletion of Malignant Stem Cells with Dasatinib vs. Imatinib in Patients with Newly Diagnosed Chronic Phase Chronic Myeloid Leuk...
    Medical condition: Chronic myeloid leukemia (CML) in chronic phase (CP) at diagnosis (untreated)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10054352 Chronic phase chronic myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-000657-29 Sponsor Protocol Number: CSTI571K2301 Start Date*: 2005-07-12
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized open-label study of 400 mg versus 800 mg of Gleevec/Glivec (imatinib mesylate) in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP)...
    Medical condition: Newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP)
    Disease: Version SOC Term Classification Code Term Level
    M15 10009013
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) ES (Completed) IT (Prematurely Ended) CZ (Prematurely Ended)
    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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