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    BIOMARKER:

    MLL rearrangement

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    Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations (AALL1131) (NCT02883049)
    Phase 3
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    02/29/2012
    Primary completion :
    12/31/2022
    Completion :
    10/03/2025
    ABL1 • BCR • RUNX1 • KMT2A • ETV6
    |
    MLL rearrangement
    |
    dasatinib • cytarabine • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • methotrexate • vincristine • prednisone • daunorubicin • clofarabine • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine delayed release (DR6MP) • mercaptopurine • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate) • cyclophosphamide intravenous
    Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders (MT2015-29) (NCT03314974)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Recruiting
    Last update posted :
    02/04/2025
    Initiation :
    03/30/2018
    Primary completion :
    06/10/2025
    Completion :
    06/10/2026
    NPM1 • KMT2A • IKZF1 • CEBPA
    |
    NPM1 mutation • MLL rearrangement
    |
    cyclophosphamide
    Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases (NCT06013423)
    Phase 2
    Fred Hutchinson Cancer Center
    Recruiting
    Last update posted :
    01/31/2025
    Initiation :
    07/23/2024
    Primary completion :
    10/31/2031
    Completion :
    10/31/2032
    KMT2A • HLA-DRB1 • HLA-B
    |
    MLL rearrangement
    |
    cyclophosphamide • fludarabine IV • thiotepa • cyclosporin A microemulsion
    Umbilical Cord Blood Transplantation From Unrelated Donors (NCT03016806)
    Phase 1
    University of Rochester
    Recruiting
    Last update posted :
    08/19/2024
    Initiation :
    06/01/2015
    Primary completion :
    06/01/2025
    Completion :
    06/01/2026
    FLT3 • KMT2A
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • melphalan • fludarabine IV • mesna • busulfan • cyclophosphamide intravenous
    Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders (NCT04644016)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    05/24/2024
    Initiation :
    11/20/2020
    Primary completion :
    12/20/2025
    Completion :
    12/20/2025
    KMT2A
    |
    MLL rearrangement • MLL rearrangement
    |
    clofarabine • fludarabine IV • busulfan • cyclosporin A microemulsion
    A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation (AUGMENT-101) (NCT04065399)
    Phase 1/2
    Syndax Pharmaceuticals
    Recruiting
    Last update posted :
    05/17/2024
    Initiation :
    11/05/2019
    Primary completion :
    12/01/2024
    Completion :
    12/01/2024
    KMT2A • NUP98
    |
    NPM1 mutation • MLL rearrangement • MLL rearrangement • NUP98 rearrangement
    |
    Revuforj (revumenib) • Tybost (cobicistat)
    Allo HSCT Using RIC and PTCy for Hematological Diseases (NCT05805605)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Recruiting
    Last update posted :
    05/07/2024
    Initiation :
    05/01/2023
    Primary completion :
    10/22/2027
    Completion :
    10/22/2028
    NPM1 • KMT2A • IKZF1 • HLA-DRB1 • CEBPA • HLA-B • HLA-C
    |
    NPM1 mutation • MLL rearrangement • MLL rearrangement • CEBPA mutation
    |
    cyclophosphamide • sirolimus • fludarabine IV
    Cord Blood Transplant in Adults With Blood Cancers (NCT05884333)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    05/02/2024
    Initiation :
    05/22/2023
    Primary completion :
    05/22/2028
    Completion :
    05/22/2028
    KMT2A
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide
    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 :
    04/10/2024
    Initiation :
    01/02/2019
    Primary completion :
    06/23/2020
    Completion :
    06/28/2024
    FLT3 • NPM1 • KMT2A • HLA-DRB1 • CEBPA
    |
    FLT3-ITD mutation • NPM1 mutation • MLL rearrangement • MLL rearrangement • CEBPA mutation • FLT3 wild-type
    |
    cyclophosphamide • melphalan • fludarabine IV • busulfan • cyclophosphamide intravenous • spanlecortemlocel (MGTA-456)
    Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies (NCT01203722)
    Phase 1/2
    Sidney Kimmel Comprehensive Cancer Center at Jo...
    Recruiting
    Last update posted :
    03/13/2024
    Initiation :
    09/01/2010
    Primary completion :
    09/01/2025
    Completion :
    12/01/2025
    FLT3 • KMT2A • HLA-DRB1 • HLA-DQB1 • HLA-B • HLA-C
    |
    Chr del(17p) • Chr del(11q) • MLL rearrangement • MLL rearrangement • Chr t(9;11)
    |
    cyclophosphamide • sirolimus • fludarabine IV • cyclophosphamide intravenous
    Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation (NCT03434730)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    03/04/2024
    Initiation :
    02/07/2018
    Primary completion :
    02/07/2025
    Completion :
    02/07/2025
    KMT2A
    |
    MLL rearrangement • MLL rearrangement
    |
    Actemra IV (tocilizumab) • cyclosporine • Neupogen (filgrastim)
    Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia (NCT00357565)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Recruiting
    Last update posted :
    01/26/2024
    Initiation :
    11/01/2005
    Primary completion :
    12/01/2025
    Completion :
    12/01/2025
    KMT2A
    |
    MLL rearrangement • MLL rearrangement
    |
    melphalan • fludarabine IV • busulfan • cyclosporine • Neupogen (filgrastim)
    Unrelated Umbilical Cord Blood Transplantation With Coinfusion of Mesenchymal Stem Cells (NCT01092026)
    Phase N/A
    Universitair Ziekenhuis Brussel
    Completed
    Last update posted :
    12/06/2023
    Initiation :
    11/01/2010
    Primary completion :
    09/01/2018
    Completion :
    09/01/2018
    FLT3 • KMT2A
    |
    MLL rearrangement • MLL rearrangement
    Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases (NCT01962636)
    Phase N/A
    Masonic Cancer Center, University of Minnesota
    Recruiting
    Last update posted :
    11/03/2023
    Initiation :
    12/01/2016
    Primary completion :
    10/01/2024
    Completion :
    10/01/2025
    KMT2A • IKZF1
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • fludarabine IV • cyclosporin A microemulsion • cyclophosphamide intravenous
    Pinometostat and Azacitidine in Treating Patients With Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia With 11q23 Rearrangement (NCT03701295)
    Phase 1/2
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    10/18/2023
    Initiation :
    03/06/2020
    Primary completion :
    12/08/2020
    Completion :
    01/12/2021
    IDH1 • IDH2 • KMT2A • HOXA9 • MEIS1
    |
    MLL rearrangement • MLL rearrangement
    |
    azacitidine • pinometostat (EPZ-5676)
    Allo HSCT Using RIC for Hematological Diseases (NCT02661035)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Completed
    Last update posted :
    09/21/2023
    Initiation :
    03/09/2017
    Primary completion :
    04/17/2023
    Completion :
    05/29/2023
    FLT3 • KMT2A • IKZF1 • HLA-DRB1 • HLA-B • HLA-C
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • fludarabine IV • cyclophosphamide intravenous • methylprednisolone sodium succinate
    BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) (NCT04187105)
    Phase 2
    University of Illinois at Chicago
    Recruiting
    Last update posted :
    09/11/2023
    Initiation :
    01/27/2020
    Primary completion :
    11/01/2024
    Completion :
    11/01/2024
    RUNX1 • ASXL1 • KMT2A • HLA-DRB1 • HLA-DQB1 • HLA-B
    |
    RUNX1 mutation • ASXL1 mutation • MLL rearrangement • MLL rearrangement • MLL translocation • Chr t(9;11)
    |
    cyclophosphamide • fludarabine IV
    Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes (NCT03121014)
    Phase 2
    University of Illinois at Chicago
    Recruiting
    Last update posted :
    07/04/2023
    Initiation :
    04/24/2017
    Primary completion :
    04/24/2024
    Completion :
    04/24/2024
    FLT3 • KMT2A • HLA-DRB1 • HLA-B • HLA-C
    |
    FLT3-ITD mutation • MLL rearrangement • MLL rearrangement • Chr t(9;11)
    |
    methotrexate • fludarabine IV • busulfan
    Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia (NCT00005585)
    Phase 3
    Children's Oncology Group
    Completed
    Last update posted :
    04/06/2023
    Initiation :
    04/01/2000
    Primary completion :
    07/01/2007
    KMT2A
    |
    MLL rearrangement • MLL rearrangement
    |
    cytarabine • cyclophosphamide • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • thioguanine • Kidrolase (L-asparaginase)
    UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep (NCT02722668)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Active, not recruiting
    Last update posted :
    02/24/2023
    Initiation :
    05/15/2017
    Primary completion :
    02/22/2023
    Completion :
    12/01/2029
    NPM1 • KMT2A • IKZF1 • CEBPA
    |
    NPM1 mutation • MLL rearrangement • MLL rearrangement • CEBPA mutation
    |
    cyclophosphamide • sirolimus • fludarabine IV • cyclophosphamide intravenous
    Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies. (NCT00739141)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Completed
    Last update posted :
    12/08/2022
    Initiation :
    08/12/2008
    Primary completion :
    10/15/2021
    Completion :
    10/15/2021
    KMT2A
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • fludarabine IV • thiotepa • cyclophosphamide intravenous
    Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant (NCT01744223)
    Phase 1/2
    Bellicum Pharmaceuticals
    Active, not recruiting
    Last update posted :
    07/12/2022
    Initiation :
    03/01/2013
    Primary completion :
    10/09/2019
    Completion :
    10/01/2032
    FLT3 • KMT2A • HLA-DRB1 • HLA-B
    |
    MLL rearrangement • MLL rearrangement • Chr t(9;11)
    |
    CaspaCIDe DLI (rimiducid activated rivogenlecleucel) • rimiducid (AP1903)
    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 • HLA-DRB1 • CEBPA • HLA-B • HLA-C
    |
    NPM1 mutation • MLL rearrangement • MLL rearrangement • CEBPA mutation
    |
    cyclophosphamide • fludarabine IV
    URMC Related Haplo-identical Donor BMT (HaploOnly) (NCT02660281)
    Phase 1
    University of Rochester
    Completed
    Last update posted :
    11/03/2021
    Initiation :
    10/01/2015
    Primary completion :
    10/28/2019
    Completion :
    01/07/2021
    FLT3 • KMT2A
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • melphalan • fludarabine IV • mesna • thiotepa • busulfan
    Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501) (NCT00412360)
    Phase 3
    Medical College of Wisconsin
    Completed
    Last update posted :
    10/28/2021
    Initiation :
    12/01/2006
    Primary completion :
    03/01/2014
    Completion :
    10/01/2014
    FLT3 • HLA-DRB1
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • fludarabine IV • cyclosporin A microemulsion • cyclophosphamide intravenous
    Azacytidine Prior to in Vivo T-cell Depleted Allo Stem Cell Transplant for Patients With Myeloid Malignancies in CR (NCT02497404)
    Phase 2
    Weill Medical College of Cornell University
    Completed
    Last update posted :
    09/22/2021
    Initiation :
    02/13/2015
    Primary completion :
    06/17/2020
    Completion :
    06/17/2021
    FLT3 • DNMT3A • RUNX1 • ASXL1 • KMT2A • SRSF2 • BCOR • U2AF1 • ZRSR2
    |
    DNMT3A mutation • ASXL1 mutation • MLL rearrangement • MLL rearrangement • U2AF1 mutation
    |
    azacitidine • Campath (alemtuzumab) • melphalan • fludarabine IV
    Comparing ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation (NCI-2018-01302) (NCT03602898)
    Phase 2
    Fred Hutchinson Cancer Center
    Withdrawn
    Last update posted :
    06/30/2021
    Initiation :
    06/01/2021
    Primary completion :
    09/17/2023
    Completion :
    09/17/2023
    FLT3 • KMT2A • HLA-DRB1
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • methotrexate • fludarabine IV • busulfan • cyclosporin A microemulsion • cyclophosphamide intravenous • methotrexate IV
    CD19-CAR_Lenti T Cells in Pediatric Patients Affected by Relapsed/Refractory CD19+ ALL and DLBCL or PML (NCT04787263)
    Phase 1/2
    Bambino Gesù Hospital and Research Institute
    Recruiting
    Last update posted :
    03/26/2021
    Initiation :
    03/04/2021
    Primary completion :
    03/03/2025
    Completion :
    03/03/2038
    TP53 • CD19 • TCF3 • PBX1
    |
    MLL rearrangement • MLL rearrangement • CD19 expression
    |
    cyclophosphamide • CD19-CAR_Lenti T cells
    Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation (NCT01338987)
    Phase 2
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    03/18/2021
    Initiation :
    04/19/2011
    Primary completion :
    12/01/2017
    Completion :
    11/19/2020
    FLT3 • ABL1 • BCR • KMT2A • HLA-DRB1 • HLA-B • HLA-C
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • methotrexate • fludarabine IV • busulfan • leuprolide acetate for depot suspension • cyclophosphamide intravenous
    Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant (NCT00305682)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Completed
    Last update posted :
    11/19/2020
    Initiation :
    06/01/2005
    Primary completion :
    12/12/2019
    Completion :
    12/12/2019
    IKZF1 • IL2RA • HLA-DRB1 • CD4 • HLA-B • ISG20
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • sirolimus • fludarabine IV • cyclophosphamide intravenous
    Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases (NCT00309842)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Completed
    Last update posted :
    09/10/2020
    Initiation :
    07/28/2005
    Primary completion :
    07/29/2019
    Completion :
    11/22/2019
    KMT2A • IKZF1
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • fludarabine IV • cyclosporine • Neupogen (filgrastim) • cyclophosphamide intravenous
    Pethema LAL-RI/2008: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia (NCT02036489)
    Phase 4
    PETHEMA Foundation
    Completed
    Last update posted :
    03/05/2020
    Initiation :
    01/01/2008
    Primary completion :
    12/01/2019
    Completion :
    12/01/2019
    ABL1 • BCR
    |
    MLL rearrangement
    |
    cytarabine • cyclophosphamide • vincristine • prednisone • daunorubicin • mercaptopurine
    Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Pilot Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source (NCT02167958)
    Phase 1
    Rafic Farah, MD
    Completed
    Last update posted :
    10/15/2019
    Initiation :
    02/11/2015
    Primary completion :
    09/21/2019
    Completion :
    09/21/2019
    FLT3 • KMT2A • HLA-DRB1 • HLA-DQB1 • HLA-B • HLA-C
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • fludarabine IV • mesna • Neupogen (filgrastim) • cyclophosphamide intravenous
    Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia (Interfant06) (NCT00550992)
    Phase N/A
    Dutch Childhood Oncology Group
    Unknown status
    Last update posted :
    07/30/2019
    Initiation :
    01/01/2006
    Primary completion :
    12/01/2020
    KMT2A • CD34
    |
    MLL rearrangement • MLL rearrangement • CD34 positive
    |
    cytarabine • cyclophosphamide • etoposide IV • vincristine • prednisone • daunorubicin • mitoxantrone • leucovorin calcium • melphalan • Oncaspar liquid (pegaspargase) • mercaptopurine • busulfan • thioguanine • cyclosporine • prednisolone
    Laboratory-Treated Lymphocyte Infusion After Haploidentical Donor Stem Cell Transplant (NCT00376480)
    Phase 1
    Dana-Farber Cancer Institute
    Completed
    Last update posted :
    07/05/2019
    Initiation :
    06/01/2005
    Primary completion :
    06/01/2010
    Completion :
    05/16/2018
    KMT2A • CD34 • HLA-B • HLA-C
    |
    MLL rearrangement • MLL rearrangement
    |
    fludarabine IV • thiotepa
    Study of Palbociclib in MLL-rearranged Acute Leukemias (NCT02310243)
    Phase 1/2
    University of Ulm
    Unknown status
    Last update posted :
    04/16/2019
    Initiation :
    07/01/2015
    Primary completion :
    07/01/2019
    Completion :
    07/01/2019
    KMT2A • CDK6
    |
    MLL rearrangement • MLL rearrangement
    |
    Ibrance (palbociclib)
    Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies (NCT01093586)
    Phase 2
    Case Comprehensive Cancer Center
    Completed
    Last update posted :
    01/23/2019
    Initiation :
    09/01/2007
    Primary completion :
    12/01/2015
    Completion :
    12/01/2015
    KMT2A • HLA-B
    |
    MLL rearrangement
    |
    cyclophosphamide • busulfan • cyclosporin A microemulsion • cyclophosphamide intravenous • methylprednisolone acetate • methylprednisolone sodium succinate
    Inducible Regulatory T Cells (iTregs) in Non-Myeloablative Sibling Donor Peripheral Blood Stem Cell Transplantation (NCT01634217)
    Phase 1
    Masonic Cancer Center, University of Minnesota
    Completed
    Last update posted :
    01/18/2019
    Initiation :
    11/08/2013
    Primary completion :
    12/01/2017
    Completion :
    12/01/2018
    KMT2A
    |
    MLL rearrangement • MLL rearrangement
    |
    sirolimus
    Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (AALL1131) (NCT01406756)
    Phase 3
    Children's Oncology Group
    Recruiting
    Last update posted :
    12/13/2017
    Initiation :
    02/01/2012
    Primary completion :
    08/01/2021
    ABL1 • BCR • RUNX1 • KMT2A • ETV6
    |
    MLL rearrangement • MLL rearrangement
    |
    cytarabine • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • methotrexate • vincristine • prednisone • dexamethasone • clofarabine • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine delayed release (DR6MP) • mercaptopurine • thioguanine • Starasid (cytarabine ocfosfate) • cyclophosphamide intravenous • dexamethasone injection • methylprednisolone sodium succinate