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Clinical trials for Acute Myeloid Leukemia (AML)

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   44394   clinical trials with a EudraCT protocol, of which   7406   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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    456 result(s) found for: Acute Myeloid Leukemia (AML). Displaying page 9 of 23.
    EudraCT Number: 2006-004912-28 Sponsor Protocol Number: EORTC06061 Start Date*: 2012-02-17
    Sponsor Name:European Organisation for Research and Treatment on Cancer
    Full Title: Clofarabine in combination with a standard remission induction regimen (AraC and idarubicin) in patients 18-60 years old with previously untreated intermediate and bad risk acute myelogenous leukem...
    Medical condition: Previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasia (MDS)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028532 Myelodysplasia LLT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002172-92 Sponsor Protocol Number: AZA-AML-004 Start Date*: 2015-04-27
    Sponsor Name:Celgene Corporation
    Full Title: A randomized, multicenter, open-label, Phase 2 study with a safety run-in part to evaluate safety, pharmacodynamics and efficacy of azacitidine compared to no anticancer treatment in children and...
    Medical condition: Treatment of children and young adults with molecular relapse of acute myeloid leukemia (AML) after first complete remission (CR1).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) DK (Completed) NL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-004830-28 Sponsor Protocol Number: CPKC412A2218 Start Date*: 2018-11-02
    Sponsor Name:Novartis Pharma AG
    Full Title: A Phase II, open-label, single arm study to evaluate the safety, efficacy, and pharmacokinetics of twice daily midostaurin (PKC412) combined with standard chemotherapy and as a single agent post-co...
    Medical condition: untreated FLT3-mutated acute myeloid leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) SI (Trial now transitioned) AT (Trial now transitioned) PL (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003395-12 Sponsor Protocol Number: ASTX727-02 Start Date*: 2019-11-14
    Sponsor Name:Astex Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Open-Label, Crossover Study of ASTX727 (Cedazuridine and Decitabine Fixed-Dose Combination) versus IV Decitabine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Mye...
    Medical condition: Acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009018 Chronic myelomonocytic leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA) CZ (Completed) HU (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-004275-40 Sponsor Protocol Number: CA212-016 Start Date*: 2018-08-21
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 1/2, Open-label Randomized Study of Ulocuplumab (BMS-936564) In Combination with Low Dose Cytarabine in Subjects with Newly Diagnosed Acute Myeloid Leukemia
    Medical condition: Subjects with Newly Diagnosed Acute Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: RO (Completed)
    Trial results: View results
    EudraCT Number: 2012-000981-40 Sponsor Protocol Number: SWEAML12-A Start Date*: 2013-01-23
    Sponsor Name:The Swedish AML Group
    Full Title: Azacitidine compared to conventional chemotherapy in consolidation of elderly patients (> 65 years) with AML in first complete remission
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10024348 Leukemia myelogenous LLT
    14.1 100000004864 10000835 Acute leukemia LLT
    14.1 100000004864 10024307 Leukaemia myelogenous LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-021719-18 Sponsor Protocol Number: KS-2009-003 Start Date*: 2011-12-02
    Sponsor Name:Hannover Medical School
    Full Title: Phase I/II study on cytarabine and idarubicine combined with escalating doses of clofarabine as induction therapy in patients with acute myeloid leukemia and high risk for induction failure (CIARA)
    Medical condition: Patients with acute myeloid leukemia (AML) and high risk for induction failure
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005408-13 Sponsor Protocol Number: 2689-CL-2004 Start Date*: 2012-09-10
    Sponsor Name:Ambit BioSciences Corporation
    Full Title: A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
    Medical condition: Acute Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-005538-12 Sponsor Protocol Number: RG_12-264(HM2052) Start Date*: 2013-08-21
    Sponsor Name:University of Birmingham
    Full Title: A Randomised Trial of the FLAMSA-BU Conditioning Regimen in Patients with Acute Myeloid Leukaemia and Myelodysplasia Undergoing Allogeneic Stem Cell Transplantation
    Medical condition: Acute Myeloid Leukaemia (AML) and Myelodysplasia (MDS)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028532 Myelodysplasia LLT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-004896-38 Sponsor Protocol Number: CL1-64315-004 Start Date*: 2020-12-07
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: Phase I/II, international, multicentre, open-label, non-randomised, non-comparative study evaluating the safety, tolerability and clinical activity of intravenously administered S64315, a selective...
    Medical condition: Acute Myeloid Leukaemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-001323-12 Sponsor Protocol Number: PEVOLAM Start Date*: 2020-09-23
    Sponsor Name:Fundación PETHEMA
    Full Title: A randomized phase III, multicentre, open label clinical trial comparing azacitidine plus pevonedistat versus azacitidine in Older/Unfit patients with newly diagnosed acute myeloid leukemia who are...
    Medical condition: Acute Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-001853-89 Sponsor Protocol Number: CLI-043 Start Date*: 2006-07-07
    Sponsor Name:Vion Pharmaceuticals, Inc
    Full Title: A phase II study of Cloretazine for elderly patients with de novo poor risk acute myelogenous leukemia.
    Medical condition: Acute Myelogenous Leukemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-000550-75 Sponsor Protocol Number: RG_05-004 Start Date*: 2006-02-24
    Sponsor Name:University of Birmingham
    Full Title: Phase II Study of the Tolerability and Efficacy of the Histone Deacetylase Inhibitor Sodium Valproate given in Conjunction with 5-azacytidine and ATRA (all trans retinoic acid ) in Patients with Ac...
    Medical condition: Patients who have Acute Myeloid Leukaemia (AML) or Myelodysplasia (MDS) will be recruited to this trial
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028532 Myelodysplasia LLT
    14.1 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: 2021-003248-26 Sponsor Protocol Number: TUD-VINC01-080 Start Date*: 2023-06-01
    Sponsor Name:Technische Universität Dresden
    Full Title: Venetoclax plus Azacitidine versus Standard intensive Chemotherapy for Patients with newly diagnosed Acute Myeloid Leukemia (AML) and NPM1 Mutations eligible for intensive Treatment (VINCENT)
    Medical condition: Patients 18-70 years eligible for intensive therapy with newly diagnosed acute myeloid leukemia (AML) harboring an NPM1 mutation and no activating FLT3 mutation
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001165-21 Sponsor Protocol Number: CHDM201I12201 Start Date*: 2022-02-15
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase Ib/II open label dose confirmation, proof of concept study of siremadlin in combination with venetoclax plus azacitidine in unfit adult AML participants who responded sub-optimally to first...
    Medical condition: Acute Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) IT (Prematurely Ended) ES (Ongoing) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-007043-14 Sponsor Protocol Number: RHMCAN0638 Start Date*: 2010-09-21
    Sponsor Name:University Hospital Southampton NHS Foundation Trust
    Full Title: A Pilot Study of Clofarabine Pre-Conditioning Prior to Full or Reduced Intensity Allogeneic Transplantation in the Treatment of High Risk Acute Myeloid Leukaemia and Myelodysplasia
    Medical condition: High risk Acute Myeloid Leukaemia and Myelodysplasia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028532 Myelodysplasia LLT
    14.1 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 (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2022-002432-31 Sponsor Protocol Number: MP0533-CP101 Start Date*: 2023-01-20
    Sponsor Name:Molecular Partners AG
    Full Title: A phase 1/2a, first-in-human, open-label, multicenter, dose escalation study of MP0533 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
    Medical condition: relapsed/refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) LT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021944-17 Sponsor Protocol Number: ClAraC-SCT-01 Start Date*: 2011-06-27
    Sponsor Name:Hannover Medical School
    Full Title: Randomized, Multi-centre, Phase II Trial to compare the Event-Free Survival of Clofarabine / Ara-C (ClAraC) or of FLAMSA Treatment in Patients with High Risk AML or Advanced MDS scheduled for Allog...
    Medical condition: Patients with high risk acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) scheduled for allogeneic stem cell transplantation (SCT).
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-000406-28 Sponsor Protocol Number: VEN-A-QUI Start Date*: 2020-09-18
    Sponsor Name:Fundación Pethema
    Full Title: A phase I-II, multicentre, open label clinical trial to assess the safety and tolerability of the combination of low-dose cytarabine or azacitidine, plus Venetoclax and Quizartinib in newly diagnos...
    Medical condition: Newly diagnosed acute myeloid leukemia patients aged equal or more than 60 years old
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10024291 Leukaemias acute myeloid HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004536-37 Sponsor Protocol Number: SHAPE Start Date*: 2020-10-19
    Sponsor Name:Leipzig University
    Full Title: Treatment of MDS/AML patients with an impending hematological relapse with azacitidine alone or in combination with pevonedistat - a randomized phase 2 trial
    Medical condition: Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS) with impending hematological relapse
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
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