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    BIOMARKER:

    NPM1 mutation

    i
    Other names: Nucleophosmin (Nucleolar Phosphoprotein B23, Numatrin), Testicular Tissue Protein Li 128, Nucleolar Protein NO38, Numatrin, NPM1, Nucleophosmin 1, Nucleophosmin/Nucleoplasmin Family, Member 1, Nucleolar Phosphoprotein B23
    Entrez ID:
    4869
    Related biomarkers:
    Expression
    Mutation
    Fusion
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    A Study to Assess the Efficacy and Safety of Entospletinib in Combination With Intensive Induction and Consolidation Chemotherapy in Adults With Newly Diagnosed Nucleophosmin 1-mutated Acute Myeloid Leukemia (KB-ENTO-3001)
    Phase 3
    Kronos Bio
    Recruiting
    Last update posted :
    05/18/2022
    Initiation :
    11/30/2021
    Primary completion :
    12/30/2023
    Completion :
    12/30/2026
    FLT3 • NPM1
    |
    FLT3 mutation • NPM1 mutation
    |
    cytarabine • entospletinib (GS-9973)
    Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance (NCT02756962)
    Phase 2
    Washington University School of Medicine
    Recruiting
    Last update posted :
    05/11/2022
    Initiation :
    07/06/2016
    Primary completion :
    07/31/2024
    Completion :
    07/31/2024
    FLT3 • NPM1 • CEBPA
    |
    FLT3-ITD mutation • NPM1 mutation • CEBPA mutation
    |
    cytarabine • Rydapt (midostaurin)
    Efficacy of Venetoclax Based Regimen in Prevention Relapse of Consecutive MRD Positive AML Patients (NCT05361057)
    Phase 2
    Institute of Hematology & Blood Diseases Hospital
    Recruiting
    Last update posted :
    05/04/2022
    Initiation :
    05/01/2022
    Primary completion :
    02/28/2023
    Completion :
    08/31/2023
    NPM1 • RUNX1 • RUNX1T1 • NUP214 • DEK
    |
    NPM1 mutation
    |
    Venclexta (venetoclax) • azacitidine • daunorubicin
    Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (NCI-2018-03465)
    Phase 1/2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    04/20/2022
    Initiation :
    02/27/2019
    Primary completion :
    01/01/2024
    Completion :
    01/01/2024
    ABL1 • BCR • NPM1 • PDGFRA • PDGFRB • CEBPA
    |
    NPM1 mutation • CEBPA mutation • PDGFRA rearrangement
    |
    Venclexta (venetoclax) • azacitidine • pevonedistat (MLN4924)
    Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders (MT2015-29)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Recruiting
    Last update posted :
    04/14/2022
    Initiation :
    03/30/2018
    Primary completion :
    01/10/2025
    Completion :
    11/10/2025
    NPM1 • IKZF1 • KMT2A • CEBPA
    |
    NPM1 mutation • MLL rearrangement • CEBPA mutation • MLL rearrangement
    |
    cyclophosphamide • mycophenolate mofetil
    DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia (NCT04752163)
    Phase 1/2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    04/13/2022
    Initiation :
    03/25/2021
    Primary completion :
    11/01/2022
    Completion :
    11/01/2022
    FLT3 • NPM1
    |
    NPM1 mutation
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • cytarabine • cyclophosphamide • azacitidine • methotrexate • vincristine • leucovorin calcium • mesna • Riabni (rituximab-arrx) • DS-1594 • Decadron (dexamethasone) • GB241 (rituximab biosimilar) • JHL1101 (rituximab biosimilar) • Neupogen (filgrastim) • Novex (rituximab biosimilar) • Noxafil (posaconazole) • TQB2303 (rituximab biosimilar) • TevaGrastim (filgrastim biosimilar) • prednisone delayed-release tablet • voriconazole
    A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant (HBO-UBC)
    Phase 2
    University of Rochester
    Recruiting
    Last update posted :
    04/11/2022
    Initiation :
    02/28/2019
    Primary completion :
    04/01/2023
    Completion :
    04/01/2023
    FLT3 • ABL1 • BCR • NPM1 • CD19 • CD22 • CD79A
    |
    FLT3-ITD mutation • NPM1 mutation
    A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation (NCT04988555)
    Phase 1/2
    Sumitomo Pharma Oncology, Inc.
    Recruiting
    Last update posted :
    04/06/2022
    Initiation :
    02/28/2022
    Primary completion :
    01/02/2025
    Completion :
    02/01/2025
    NPM1
    |
    NPM1 mutation
    |
    DSP-5336 • Noxafil (posaconazole) • fluconazole oral
    Venetoclax and Azacitidine for the Management of Molecular Relapse/Progression in Adult NPM1-mutated Acute Myeloid Leukemia (NCT04867928)
    Phase 2
    Gruppo Italiano Malattie EMatologiche dell'Adulto
    Recruiting
    Last update posted :
    03/16/2022
    Initiation :
    03/01/2022
    Primary completion :
    01/01/2025
    Completion :
    01/01/2025
    FLT3 • ABL1 • NPM1
    |
    NPM1 mutation
    |
    Venclexta (venetoclax) • azacitidine
    MRD-guided Treatment in NPM1mut AML Patients (PEMAZA)
    Phase 2
    Technische Universität Dresden
    Recruiting
    Last update posted :
    03/14/2022
    Initiation :
    08/21/2019
    Primary completion :
    08/01/2023
    Completion :
    08/01/2024
    NPM1
    |
    NPM1 mutation
    |
    Keytruda (pembrolizumab) • azacitidine
    Treatment of MDS/AML Patients With an Impending Hematological Relapse With AZA or ATA and Pevonedistat (NCT04712942)
    Phase 2
    University of Leipzig
    Active, not recruiting
    Last update posted :
    01/24/2022
    Initiation :
    01/01/2021
    Primary completion :
    11/01/2023
    Completion :
    11/01/2024
    KIT • NPM1 • CD34
    |
    NPM1 mutation
    |
    azacitidine • pevonedistat (MLN4924)
    Study to Assess an Interphase Cycle With Flotetuzumab. (HOVON162AML)
    Phase 2
    Stichting Hemato-Oncologie voor Volwassenen Ned...
    Withdrawn
    Last update posted :
    12/22/2021
    Initiation :
    01/01/2022
    Primary completion :
    08/01/2024
    Completion :
    12/01/2026
    NPM1
    |
    NPM1 mutation
    |
    flotetuzumab (MGD006)
    Double Cord Versus Haploidentical (BMT CTN 1101) (NCT01597778)
    Phase 3
    Medical College of Wisconsin
    Completed
    Last update posted :
    12/01/2021
    Initiation :
    06/01/2012
    Primary completion :
    09/11/2020
    Completion :
    09/11/2020
    NPM1 • CEBPA • HLA-DRB1 • HLA-B • HLA-C
    |
    NPM1 mutation • MLL rearrangement • CEBPA mutation • MLL rearrangement
    |
    cyclophosphamide • fludarabine IV • mycophenolate mofetil • tacrolimus intravenous • tacrolimus oral
    UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep (NCT02722668)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Recruiting
    Last update posted :
    11/05/2021
    Initiation :
    05/15/2017
    Primary completion :
    05/01/2028
    Completion :
    12/01/2029
    NPM1 • IKZF1 • KMT2A • CEBPA
    |
    NPM1 mutation • MLL rearrangement • CEBPA mutation • MLL rearrangement
    |
    cyclophosphamide • sirolimus • fludarabine IV • mycophenolate mofetil
    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 Adult Patients With Hematologic Malignancies (HTLP-ONCO)
    Phase 1/2
    Assistance Publique - Hôpitaux de Paris
    Recruiting
    Last update posted :
    10/29/2021
    Initiation :
    10/01/2021
    Primary completion :
    09/01/2023
    Completion :
    05/01/2025
    FLT3 • NPM1 • CD8 • CD34 • HLA-DRB1 • CD4 • CD27 • CD7
    |
    FLT3-ITD mutation • NPM1 mutation
    Study of Chemotherapy in Combination With All-trans Retinoic Acid (ATRA) With or Without Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia (AML) and Mutant Nucleophosmin-1 (NPM1) Gene Mutation (NCT00893399)
    Phase 3
    University of Ulm
    Completed
    Last update posted :
    09/29/2021
    Initiation :
    05/12/2010
    Primary completion :
    09/01/2021
    Completion :
    09/01/2021
    NPM1
    |
    NPM1 mutation
    |
    Mylotarg (gemtuzumab ozogamicin)
    Efficacy and Safety of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia (ADVANCE-II)
    Phase 2
    DCPrime BV
    Active, not recruiting
    Last update posted :
    09/08/2021
    Initiation :
    10/15/2018
    Primary completion :
    03/01/2022
    Completion :
    12/01/2022
    NPM1
    |
    NPM1 mutation
    |
    DCP-001
    Molecular Diagnostic Platform for AML (NCT04446741)
    Phase N/A
    PETHEMA Foundation
    Recruiting
    Last update posted :
    09/06/2021
    Initiation :
    10/01/2019
    Primary completion :
    10/01/2022
    Completion :
    10/01/2022
    TP53 • FLT3 • NPM1 • IDH2 • RUNX1 • WT1 • CEBPA • PHF6 • RAD21 • SMC1A
    |
    NPM1 mutation • CEBPA mutation • U2AF1 mutation
    Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia (NCT02144675)
    Phase 2
    Rutgers, The State University of New Jersey
    Completed
    Last update posted :
    08/24/2021
    Initiation :
    01/01/2009
    Primary completion :
    04/26/2016
    Completion :
    04/26/2016
    FLT3 • NPM1
    |
    NPM1 mutation
    |
    cytarabine • idarubicin hydrochloride
    Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy (NCT03674411)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Active, not recruiting
    Last update posted :
    08/16/2021
    Initiation :
    01/02/2019
    Primary completion :
    07/01/2023
    Completion :
    08/01/2023
    FLT3 • NPM1 • KMT2A • CEBPA • HLA-DRB1
    |
    FLT3-ITD mutation • NPM1 mutation • MLL rearrangement • CEBPA mutation • MLL rearrangement • FLT3 wild-type
    |
    cyclophosphamide • melphalan • fludarabine IV • busulfan • mycophenolate mofetil • spanlecortemlocel (MGTA-456) • tacrolimus intravenous
    A Study of SNDX-5613 in R/R Leukemias Including Those With an MLLr/KMT2A Gene Rearrangement or NPM1 Mutation (AUGMENT-101)
    Phase 1/2
    Syndax Pharmaceuticals
    Recruiting
    Last update posted :
    05/06/2021
    Initiation :
    11/05/2019
    Primary completion :
    07/01/2022
    Completion :
    01/01/2024
    KMT2A
    |
    NPM1 mutation • MLL rearrangement • MLL rearrangement
    |
    revumenib (SNDX-5613) • Tybost (cobicistat)
    CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia (NCT04231851)
    Phase 2
    University of California, Irvine
    Recruiting
    Last update posted :
    04/13/2021
    Initiation :
    02/19/2020
    Primary completion :
    09/30/2021
    Completion :
    09/30/2022
    NPM1 • CEBPA
    |
    NPM1 mutation
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation) • Daurismo (glasdegib)
    Oral Arsenic Trioxide for NPM1-mutated AML (NCT04689815)
    Phase 2
    The University of Hong Kong
    Recruiting
    Last update posted :
    12/31/2020
    Initiation :
    01/01/2021
    Primary completion :
    12/31/2023
    Completion :
    12/31/2024
    NPM1
    |
    NPM1 mutation
    |
    azacitidine • arsenic trioxide
    Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR (BIG-1)
    Phase 2/3
    University Hospital, Angers
    Recruiting
    Last update posted :
    10/20/2020
    Initiation :
    01/01/2015
    Primary completion :
    06/01/2024
    FLT3 • NPM1
    |
    FLT3-ITD mutation • NPM1 mutation
    |
    Venclexta (venetoclax) • cytarabine • daunorubicin • idarubicin hydrochloride • dexamethasone • Qinprezo (vosaroxin) • cyclosporine • mycophenolate mofetil
    Ponatinib for FLT3-ITD Acute Myelogenous Leukemia (NCT02428543)
    Phase 1/2
    Versailles Hospital
    Active, not recruiting
    Last update posted :
    08/10/2020
    Initiation :
    07/01/2013
    Primary completion :
    11/01/2020
    Completion :
    11/01/2023
    FLT3 • NPM1 • WT1
    |
    FLT3-ITD mutation • FLT3 mutation • NPM1 mutation • NPM1 expression • FLT3 wild-type
    |
    Iclusig (ponatinib) • cytarabine
    DNA Analysis of Tumor Tissue From Patients With Acute Myeloid Leukemia (NCT00897936)
    Phase N/A
    ECOG-ACRIN Cancer Research Group
    Completed
    Last update posted :
    07/31/2020
    Initiation :
    03/23/2006
    Primary completion :
    10/15/2009
    Completion :
    10/15/2009
    NPM1
    |
    NPM1 mutation
    Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia (NCT03031249)
    Phase 1/2
    Institute of Hematology & Blood Diseases Hospital
    Recruiting
    Last update posted :
    03/20/2020
    Initiation :
    02/08/2017
    Primary completion :
    12/01/2021
    Completion :
    12/01/2022
    NPM1
    |
    NPM1 mutation
    |
    cytarabine • Vesanoid (tretinoin) • arsenic trioxide
    A Study of Safety, Efficacy and Pharmacodynamics of Azacitidine in Children and Young Adults With Acute Myeloid Leukemia. (NCT02450877)
    Phase 2
    Celgene
    Completed
    Last update posted :
    12/20/2019
    Initiation :
    08/12/2015
    Primary completion :
    10/10/2018
    Completion :
    10/08/2019
    FLT3 • NPM1 • RUNX1 • KMT2A • RUNX1T1
    |
    FLT3-ITD mutation • NPM1 mutation • MLL rearrangement
    |
    azacitidine
    A Phase I Study of NK Cell Infusion Following Allogeneic Peripheral Blood Stem Cell Transplantation From Related or Matched Unrelated Donors in Pediatric Patients With Solid Tumors and Leukemias (NCT01287104)
    Phase 1
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    08/22/2019
    Initiation :
    01/29/2011
    Primary completion :
    06/28/2018
    Completion :
    06/28/2018
    FLT3 • NPM1 • CEBPA • CD4
    |
    FLT3-ITD mutation • NPM1 mutation • CEBPA mutation • Chr del(5q)
    |
    peripheral blood stem cell transplantation
    A Phase I, Two-part Study to Determine the Recommended Dose and Evaluate the Safety and Tolerability of a Novel Oral Arsenic Trioxide Formulation (ORH-2014) in Subjects With Advanced Hematological Disorders (NCT03048344)
    Phase 1
    Orsenix LLC
    Completed
    Last update posted :
    03/25/2019
    Initiation :
    12/02/2016
    Primary completion :
    02/28/2019
    Completion :
    02/28/2019
    NPM1
    |
    NPM1 mutation
    |
    arsenic trioxide • arsenic trioxide oral (SY-2101)
    WT-1 Analog Peptide Vaccine in Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) (NCT01266083)
    Phase 2
    Sellas Life Sciences Group
    Completed
    Last update posted :
    11/30/2018
    Initiation :
    12/01/2010
    Primary completion :
    02/01/2018
    Completion :
    02/01/2018
    FLT3 • NPM1 • WT1
    |
    NPM1 mutation
    |
    Zeltherva (galinpepimut-S)
    DC Vaccination for Postremission Therapy in AML (NCT01734304)
    Phase 1/2
    Ludwig-Maximilians - University of Munich
    Completed
    Last update posted :
    10/12/2018
    Initiation :
    11/05/2013
    Primary completion :
    03/31/2018
    Completion :
    09/30/2018
    NPM1
    |
    NPM1 mutation
    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 NPM1 Mutation (NCT01237808)
    Phase 3
    University of Ulm
    Completed
    Last update posted :
    08/01/2018
    Initiation :
    03/01/2011
    Primary completion :
    07/13/2018
    Completion :
    07/13/2018
    NPM1
    |
    NPM1 mutation
    |
    cytarabine • etoposide IV
    Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT01835288)
    Phase 2
    Stanford University
    Withdrawn
    Last update posted :
    05/21/2018
    Initiation :
    05/01/2013
    Primary completion :
    05/01/2015
    NPM1
    |
    NPM1 mutation
    |
    arsenic trioxide
    Treg Cells for AGVHD in Non-myeloablative UCB Transplant (NCT02118311)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Withdrawn
    Last update posted :
    12/01/2017
    Initiation :
    06/01/2016
    Primary completion :
    09/01/2018
    Completion :
    09/01/2018
    NPM1 • KMT2A • CEBPA • HLA-DRB1 • HLA-B
    |
    NPM1 mutation • MLL rearrangement • CEBPA mutation • MLL rearrangement
    |
    cyclophosphamide • fludarabine IV
    CNDO-109-AANK for AML in First Complete Remission (CR1) (NCT01520558)
    Phase 1/2
    Coronado Biosciences, Inc.
    Active, not recruiting
    Last update posted :
    06/29/2017
    Initiation :
    12/01/2012
    Primary completion :
    03/01/2016
    Completion :
    02/01/2018
    FLT3 • NPM1 • HLA-B
    |
    FLT3 mutation • NPM1 mutation • Chr del(5q)
    |
    CNDO-109
    S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia (NCT01575535)
    Phase N/A
    Southwest Oncology Group
    Completed
    Last update posted :
    03/06/2015
    Initiation :
    04/01/2012
    Primary completion :
    05/01/2012
    Completion :
    05/01/2012
    FLT3 • NPM1 • CEBPA • CD33
    |
    FLT3-ITD mutation • NPM1 mutation