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Clinical trials for NPM1

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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    38 result(s) found for: NPM1. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2010-023409-37 Sponsor Protocol Number: AMLSG_15-10 Start Date*: 2011-03-02
    Sponsor Name:University Hospital Ulm
    Full Title: Randomized Phase III Study of Low-Dose Cytarabine and Etoposide with or without All-Trans Retinoic Acid in Older Patients not Eligible for Intensive Chemotherapy with Acute Myeloid Leukemia and NPM...
    Medical condition: Adult patients (>60) with AML and NPM1 mutation ineligible for intensive chemotherapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-011889-28 Sponsor Protocol Number: AMLSG09-09 Start Date*: 2010-02-08
    Sponsor Name:University of Ulm
    Full Title: Phase III study of chemotherapy in combination with ATRA with or without gemtuzumab ozogamicin in patients with acute myeloid leukemia and NPM1 gene mutation
    Medical condition: adult patients with AML and NPM1 mutation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2010-022388-37 Sponsor Protocol Number: TUD-RELA02-048 Start Date*: 2011-09-23
    Sponsor Name:Technische Universität Dresden
    Full Title: Treatment of patients with MDS or AML with an impending hematological relapse with Azacitidin (Vidaza)
    Medical condition: Patients with AML or MDS >= 18 years of age after conventional chemotherapy or stem cell transplantation with significant residual disease or an increase of MRD (e.g. t(6,9), NPM1 or CD34+ or CD117...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10060557 Acute myelocytic leukemia LLT
    20.0 100000004864 10028534 Myelodysplastic syndrome NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-002933-36 Sponsor Protocol Number: ALFA-0701 Study (Mylofrance 3) Start Date*: 2007-11-02
    Sponsor Name:CH-Versailles
    Full Title: Etude de phase 3 randomisée multicentrique étudiant l’effet de l’addition de l’anticorps monoclonal Gemtuzumab Ozogamicin (Mylotarg) utilisé en doses fractionnées au traitement d’induction et de co...
    Medical condition: The standard regimen for AML is the with Mylotarg, 3 mg/m2 given on days 1,4 and 7.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    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: 2014-000693-18 Sponsor Protocol Number: ActD-AML-PG01 Start Date*: 2014-05-27
    Sponsor Name:Dipartimento di Medicina, Università di Perugia
    Full Title: A PHASE II STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF ACTINOMYCIN D IN PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA WITH NUCLEOPHOSMIN (NPM1) GENE MUTATION
    Medical condition: Relapsed/refractory acute myeloid leukemia
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-002885-34 Sponsor Protocol Number: CHIP-AML22/Master Start Date*: 2023-03-17
    Sponsor Name:Princess Máxima Center
    Full Title: CHIP-AML22 Master protocol: An open label complex clinical trial in newly diagnosed pediatric de novo AML patients – a study by the NOPHO-DB-SHIP consortium
    Medical condition: Acute Myeloid Leukemia
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-000380-46 Sponsor Protocol Number: 75276617ALE1003 Start Date*: 2022-12-27
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase I/Ib Study of JNJ-75276617 in Combination with Conventional Chemotherapy for Pediatric and Young Adult Participants with Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleo...
    Medical condition: Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000844 Acute lymphoblastic leukaemia LLT
    21.0 100000004864 10060354 Acute myeloblastic leukaemia LLT
    21.0 100000004864 10000833 Acute leukaemia of unspecified cell type LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003490-41 Sponsor Protocol Number: AML-PG02 Start Date*: 2016-09-09
    Sponsor Name:PROF.BRUNANGELO FALINI,DR.SSA MARIA PAOLA MARTELLI,UNIVERSITA' DI PERUGIA
    Full Title: A PHASE 2A STUDY ON THE CLINICAL ACTIVITY AND SAFETY OF ACTINOMYCIN-D IN PATIENTS WITH NPM1-MUTATED AML AGED =70 YEARS AND/OR UNFIT FOR INTENSIVE CHEMOTHERAPY, EITHER NEWLY DIAGNOSED OR PREVIOUSLY ...
    Medical condition: NPM1-MUTATED AML NEWLY DIAGNOSED OR PREVIOUSLY TREATED WITH HYPOMETHYLATING AGENTS
    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
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002361-17 Sponsor Protocol Number: AML2521 Start Date*: 2021-11-17
    Sponsor Name:FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
    Full Title: A multicentric phase 2 study of venetoclax and azacitidine for the management of the molecular relapse/progression in adult NPM1- mutaded acute myeloid leukemia.
    Medical condition: Acute Myeloid Leukemia with NPM1 mutation.
    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) 10000880 Acute myeloid leukaemia PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10081513 Acute myeloid leukaemia refractory PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060558 Acute myeloid leukemia recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-004050-16 Sponsor Protocol Number: HEAT-AML Start Date*: 2019-08-01
    Sponsor Name:University Hospital Karolinska
    Full Title: HEAT-AML (Hydroxyurea-Enhanced Ara-C Treatment of Adult Acute Myeloid Leukaemia): A phase I/II multicenter study to assess the tolerability and efficacy of the addition of hydroxyurea to standard a...
    Medical condition: Newly diagnosed acute myeloid leukaemia (AML) in patients ≥ 18 years of age
    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: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003422-32 Sponsor Protocol Number: AMoRe2017 Start Date*: 2018-04-25
    Sponsor Name:Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH) gGmbH
    Full Title: INTERNATIONAL MULTICENTER, OPEN-LABEL, PHASE 2 STUDY TO TREAT MOLECULAR RELAPSE OF PEDIATRIC ACUTE MYELOID LEUKEMIA WITH AZACITIDINE
    Medical condition: Intravenous azacitidine 100 mg/m2, Days 1 to 7 of a 28-day cycle for up to 3 cycles initially. In case of decline of MRD during azacitidine treatment additional cycles are allowed (maximum 6 cycl...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) NL (Prematurely Ended) SE (Completed) BE (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-016142-44 Sponsor Protocol Number: AMLSG12-09 Start Date*: 2010-10-11
    Sponsor Name:University Hospital Ulm
    Full Title: Randomized phase-II trial evaluating induction therapy with idarubicin and etoposide plus sequential or concurrent azacitidine and maintenance therapy with azacitidine
    Medical condition: Patients with suspected diagnosis of acute myeloid leukemia or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the WHO classification) (>=18years) Exclus...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    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
    EudraCT Number: 2014-000699-24 Sponsor Protocol Number: PHRC2010-03 Start Date*: 2014-10-02
    Sponsor Name:CHU Angers-DAMR
    Full Title: Essai de phase 3 visant à améliorer la survie globale des LAM de l’adulte de 18 à 60 ans en comparant l’idarubicine à forte dose à la daunorubicine à l’induction, la cytarabine à haute-dose et à do...
    Medical condition: Leucémie aiguë myéloïde
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    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: 2019-001976-12 Sponsor Protocol Number: FLAG-QUIDA Start Date*: 2019-09-12
    Sponsor Name:Fundación Pethema
    Full Title: A multicenter, prospective, non-randomized, Phase I-II trial to assess the efficacy and safety of the combination of oral quizartinib and the FLAG-IDA chemotherapy regimen in first relapsed/refract...
    Medical condition: relapsed/refractory 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 (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-022446-24 Sponsor Protocol Number: 2011-01 Start Date*: 2013-10-10
    Sponsor Name:Hospital of the Ludwig Maximilians University Munich
    Full Title: Active immunotherapy of patients with acute myeloid leukemia using autologous dendritic cells transfected with RNA encoding leukemia-associated antigens
    Medical condition: Male and female patients with AML of non-favorable risk profile not eligible for allogeneic stem cell transplantation
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10000878 Acute myeloblastic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004883-23 Sponsor Protocol Number: APHP191116 Start Date*: 2020-10-06
    Sponsor Name:APHP
    Full Title: A phase I/II Study evaluating the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after umbilical cord blood (UCB) transplantation in adu...
    Medical condition: Adult patients (n=10) requiring an allogeneic HSCT for the treatment of AML with an unfavorable prognosis according to international criteria in first complete remission or second complete remissio...
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000881 Acute myeloid leukaemia (in remission) PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004110-25 Sponsor Protocol Number: TUD-PEMAZA-068 Start Date*: 2018-12-14
    Sponsor Name:Technische Universität Dresden
    Full Title: MRD-guided treatment with pembrolizumab and azacitidine in NPM1mut AML patients with an imminent hematological relapse
    Medical condition: Patients with NPM1mut AML >= 18 years in CR presenting with MRD after conventional 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: DE (Trial now transitioned)
    Trial results: (No results available)
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