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Clinical trials for Gilteritinib

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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    8 result(s) found for: Gilteritinib. Displaying page 1 of 1.
    EudraCT Number: 2018-002301-61 Sponsor Protocol Number: 2215-CL-0603 Start Date*: 2020-01-14
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Ty...
    Medical condition: FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-001643-39 Sponsor Protocol Number: 2215-CL-0302 Start Date*: 2017-02-09
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo- Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy...
    Medical condition: Subjects diagnosed with FLT3/ITD acute myeloid leukemia (AML) in CR1, including CRp and CRi, for whom a decision not to proceed with transplantation has been made, or a suitable donor could not be ...
    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 (Completed) ES (Completed) CZ (Completed) PL (Completed) PT (Completed) SE (Completed) GR (Completed) DK (Completed) HR (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-001279-15 Sponsor Protocol Number: KB-LANRA-1001 Start Date*: 2022-11-22
    Sponsor Name:Kronos Bio, Inc.
    Full Title: A Phase 1b/2 study of the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the selective SYK inhibitor lanraplenib (LANRA) in combination with the FLT3 inhibitor gilteritinib...
    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: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-001813-35 Sponsor Protocol Number: 2020/65 Start Date*: 2022-04-21
    Sponsor Name:Centre Antoine Lacassagne
    Full Title: AGORA-1 /ALFA 2100 study : A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults with FLT3-ITD relapse/refractory (R/R) AML
    Medical condition: Adult patients (aged 18 years old or more) with a newly diagnosis of relapsed/refractory (R/R) AML associated to the presence a FLT3 gene internal tandem duplication (FLT3-ITD).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10001941 AML LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-001061-83 Sponsor Protocol Number: 2215-CL-0304 Start Date*: 2017-07-13
    Sponsor Name:Astellas Pharma Global Development, Inc.
    Full Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with...
    Medical condition: FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) (FLT3/ITD) acute myeloid leukemia (AML) in first morphologic complete remission (CR1) that has been treated with allogeneic hem...
    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 (Temporarily Halted) GB (GB - no longer in EU/EEA) ES (Ongoing) BE (Completed) PL (Completed) DK (Completed) FR (Ongoing) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000624-33 Sponsor Protocol Number: HO156_AMLSG28/18 Start Date*: 2019-08-01
    Sponsor Name:HOVON Foundation
    Full Title: A phase 3, multicenter, open-label, randomized, study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one-year maintenance in patients with ne...
    Medical condition: Previously untreated Acute Myeloid Leukemia (AML) or Myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001941 AML LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) SE (Trial now transitioned) LT (Trial now transitioned) BE (Trial now transitioned) FI (Trial now transitioned) FR (Trial now transitioned) IE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-001790-41 Sponsor Protocol Number: 2215-CL-0201 Start Date*: 2016-06-07
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: A Phase 3 Multicenter, Open-label, Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukem...
    Medical condition: Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy
    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: BE (Trial now transitioned) DE (Trial now transitioned) GB (GB - no longer in EU/EEA) ES (Ongoing) FR (Completed) PL (Completed) HU (Prematurely Ended) GR (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002217-31 Sponsor Protocol Number: 2215-CL-0101 Start Date*: 2015-07-09
    Sponsor Name:Astellas Pharma Global Development, Inc.
    Full Title: A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
    Medical condition: Relapsed or Refractory Acute Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) FR (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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