[{"id":"38aae3c4-f386-4a60-a95e-c6b46ee44656","acronym":"","url":"https://clinicaltrials.gov/study/NCT05656248","created_at":"2022-12-19T14:58:46.031Z","updated_at":"2025-02-25T14:41:44.924Z","phase":"Phase 2","brief_title":"Study of CPX-351 (VYXEOS) in Individuals \u003c 22 Years With Secondary Myeloid Neoplasms","source_id_and_acronym":"NCT05656248","lead_sponsor":"St. Jude Children's Research Hospital","biomarkers":" TP53 • NF1 • RUNX1 • ETV6 • CEBPA • CD4 • MECOM • GATA2 • ANKRD26","pipe":"","alterations":" ","tags":["TP53 • NF1 • RUNX1 • ETV6 • CEBPA • CD4 • MECOM • GATA2 • ANKRD26"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Vyxeos (cytarabine/daunorubicin liposomal formulation)"],"overall_status":"Recruiting","enrollment":" Enrollment 25","initiation":"Initiation: 01/17/2023","start_date":" 01/17/2023","primary_txt":" Primary completion: 08/01/2025","primary_completion_date":" 08/01/2025","study_txt":" Completion: 08/01/2028","study_completion_date":" 08/01/2028","last_update_posted":"2025-02-14"},{"id":"99225106-dfaa-4574-8f8a-c62a8252d206","acronym":"","url":"https://clinicaltrials.gov/study/NCT04293562","created_at":"2021-01-18T20:50:03.431Z","updated_at":"2025-02-25T15:11:29.634Z","phase":"Phase 3","brief_title":"A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations","source_id_and_acronym":"NCT04293562","lead_sponsor":"Children's Oncology Group","biomarkers":" FLT3","pipe":"","alterations":" ","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Erwinase (erwinia asparaginase) • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate) • dexrazoxane"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 1186","initiation":"Initiation: 07/21/2020","start_date":" 07/21/2020","primary_txt":" Primary completion: 09/30/2027","primary_completion_date":" 09/30/2027","study_txt":" Completion: 09/30/2027","study_completion_date":" 09/30/2027","last_update_posted":"2025-02-13"},{"id":"5a8a1ba9-7750-4d42-886f-26c4d198762e","acronym":"NCI-2018-01812","url":"https://clinicaltrials.gov/study/NCT03672539","created_at":"2021-01-18T18:00:52.647Z","updated_at":"2025-02-25T15:43:12.491Z","phase":"Phase 2","brief_title":"Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome","source_id_and_acronym":"NCT03672539 - NCI-2018-01812","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" CD33","pipe":" | ","alterations":" CD33 positive","tags":["CD33"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e CD33 positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)"],"overall_status":"Recruiting","enrollment":" Enrollment 50","initiation":"Initiation: 11/07/2018","start_date":" 11/07/2018","primary_txt":" Primary completion: 11/30/2025","primary_completion_date":" 11/30/2025","study_txt":" Completion: 11/30/2025","study_completion_date":" 11/30/2025","last_update_posted":"2025-02-10"},{"id":"5adabdf3-1484-4c8e-ac66-a9230e113fb0","acronym":"","url":"https://clinicaltrials.gov/study/NCT04915612","created_at":"2021-06-07T15:53:27.598Z","updated_at":"2025-02-25T15:35:05.555Z","phase":"Phase 1","brief_title":"Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia","source_id_and_acronym":"NCT04915612","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" CD33","pipe":" | ","alterations":" CD33 positive","tags":["CD33"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e CD33 positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)"],"overall_status":"Completed","enrollment":" Enrollment 1","initiation":"Initiation: 05/21/2021","start_date":" 05/21/2021","primary_txt":" Primary completion: 01/30/2025","primary_completion_date":" 01/30/2025","study_txt":" Completion: 01/30/2025","study_completion_date":" 01/30/2025","last_update_posted":"2025-02-10"},{"id":"d48274bb-de2d-4319-b258-4def71b8a13e","acronym":"","url":"https://clinicaltrials.gov/study/NCT05558124","created_at":"2022-09-28T14:56:07.027Z","updated_at":"2025-02-25T16:33:08.602Z","phase":"Phase 1","brief_title":"CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML","source_id_and_acronym":"NCT05558124","lead_sponsor":"H. Lee Moffitt Cancer Center and Research Institute","biomarkers":" CD33","pipe":"","alterations":" ","tags":["CD33"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)"],"overall_status":"Recruiting","enrollment":" Enrollment 18","initiation":"Initiation: 02/16/2023","start_date":" 02/16/2023","primary_txt":" Primary completion: 11/01/2025","primary_completion_date":" 11/01/2025","study_txt":" Completion: 11/01/2025","study_completion_date":" 11/01/2025","last_update_posted":"2025-02-07"},{"id":"ee309a82-4f0b-426f-a0b1-deeeabf2fd59","acronym":"","url":"https://clinicaltrials.gov/study/NCT04802161","created_at":"2021-03-17T15:57:34.517Z","updated_at":"2025-02-25T16:32:23.537Z","phase":"Phase 2","brief_title":"Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes","source_id_and_acronym":"NCT04802161","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" RUNX1 • SF3B1 • ASXL1 • SRSF2 • BCOR • U2AF1 • STAG2 • ZRSR2","pipe":" | ","alterations":" Chr del(11q)","tags":["RUNX1 • SF3B1 • ASXL1 • SRSF2 • BCOR • U2AF1 • STAG2 • ZRSR2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Chr del(11q)"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Vyxeos (cytarabine/daunorubicin liposomal formulation) • pomalidomide • thalidomide"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 78","initiation":"Initiation: 08/24/2022","start_date":" 08/24/2022","primary_txt":" Primary completion: 12/31/2025","primary_completion_date":" 12/31/2025","study_txt":" Completion: 12/31/2025","study_completion_date":" 12/31/2025","last_update_posted":"2025-02-07"},{"id":"55079916-4788-41a0-a5ca-a4084d122a58","acronym":"","url":"https://clinicaltrials.gov/study/NCT05024552","created_at":"2021-08-27T12:52:57.710Z","updated_at":"2024-07-02T16:34:26.210Z","phase":"Phase 1","brief_title":"Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML","source_id_and_acronym":"NCT05024552","lead_sponsor":"H. Lee Moffitt Cancer Center and Research Institute","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3-TKD mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3-TKD mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Xospata (gilteritinib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)"],"overall_status":"Recruiting","enrollment":" Enrollment 22","initiation":"Initiation: 08/23/2021","start_date":" 08/23/2021","primary_txt":" Primary completion: 08/01/2024","primary_completion_date":" 08/01/2024","study_txt":" Completion: 08/01/2025","study_completion_date":" 08/01/2025","last_update_posted":"2024-06-13"},{"id":"4b7d8253-b538-4d01-afbf-759acf0e19ab","acronym":"","url":"https://clinicaltrials.gov/study/NCT04801797","created_at":"2021-03-17T16:56:59.748Z","updated_at":"2024-07-02T16:35:14.237Z","phase":"Phase 2","brief_title":"Venetoclax + Azacitidine vs. Induction Chemotherapy in AML","source_id_and_acronym":"NCT04801797","lead_sponsor":"Massachusetts General Hospital","biomarkers":" BCL2","pipe":"","alterations":" ","tags":["BCL2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • azacitidine • Vyxeos (cytarabine/daunorubicin liposomal formulation) • idarubicin hydrochloride"],"overall_status":"Recruiting","enrollment":" Enrollment 172","initiation":"Initiation: 05/20/2021","start_date":" 05/20/2021","primary_txt":" Primary completion: 01/01/2025","primary_completion_date":" 01/01/2025","study_txt":" Completion: 01/01/2026","study_completion_date":" 01/01/2026","last_update_posted":"2024-03-18"},{"id":"6053286c-83b6-47bb-9279-55103c8270d9","acronym":"","url":"https://clinicaltrials.gov/study/NCT04493164","created_at":"2021-01-18T21:35:03.148Z","updated_at":"2024-07-02T16:35:14.734Z","phase":"Phase 2","brief_title":"CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","source_id_and_acronym":"NCT04493164","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" IDH1","pipe":" | ","alterations":" IDH1 R132","tags":["IDH1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e IDH1 R132"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Tibsovo (ivosidenib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)"],"overall_status":"Recruiting","enrollment":" Enrollment 30","initiation":"Initiation: 12/30/2020","start_date":" 12/30/2020","primary_txt":" Primary completion: 06/01/2025","primary_completion_date":" 06/01/2025","study_txt":" Completion: 06/01/2025","study_completion_date":" 06/01/2025","last_update_posted":"2024-03-15"},{"id":"ffb94954-f1c1-4247-b33c-267b8f6f3014","acronym":"","url":"https://clinicaltrials.gov/study/NCT04231851","created_at":"2021-01-18T20:35:11.661Z","updated_at":"2024-07-02T16:35:20.841Z","phase":"Phase 2","brief_title":"CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia","source_id_and_acronym":"NCT04231851","lead_sponsor":"University of California, Irvine","biomarkers":" NPM1 • CEBPA","pipe":" | ","alterations":" NPM1 mutation","tags":["NPM1 • CEBPA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e NPM1 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Vyxeos (cytarabine/daunorubicin liposomal formulation) • Daurismo (glasdegib)"],"overall_status":"Recruiting","enrollment":" Enrollment 30","initiation":"Initiation: 02/19/2020","start_date":" 02/19/2020","primary_txt":" Primary completion: 06/01/2024","primary_completion_date":" 06/01/2024","study_txt":" Completion: 09/30/2025","study_completion_date":" 09/30/2025","last_update_posted":"2024-02-05"},{"id":"1560bbb5-7437-45d5-a622-52082301f5bd","acronym":"V2-MA-1801","url":"https://clinicaltrials.gov/study/NCT03826992","created_at":"2021-03-31T17:52:40.794Z","updated_at":"2024-07-02T16:35:22.261Z","phase":"Phase 1","brief_title":"Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia","source_id_and_acronym":"NCT03826992 - V2-MA-1801","lead_sponsor":"Children's Hospital Medical Center, Cincinnati","biomarkers":" KMT2A","pipe":" | ","alterations":" MLL rearrangement","tags":["KMT2A"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MLL rearrangement"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • Vyxeos (cytarabine/daunorubicin liposomal formulation)"],"overall_status":"Recruiting","enrollment":" Enrollment 21","initiation":"Initiation: 12/27/2018","start_date":" 12/27/2018","primary_txt":" Primary completion: 01/01/2025","primary_completion_date":" 01/01/2025","study_txt":" Completion: 01/01/2026","study_completion_date":" 01/01/2026","last_update_posted":"2024-01-25"},{"id":"2081d67d-68ba-4944-9cbd-65ba437e972d","acronym":"","url":"https://clinicaltrials.gov/study/NCT05627232","created_at":"2024-01-05T19:19:11.024Z","updated_at":"2024-07-02T16:35:24.396Z","phase":"Phase 1","brief_title":"Palbociclib or Tazemetostat in Combination With CPX-351 for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","source_id_and_acronym":"NCT05627232","lead_sponsor":"Thomas Jefferson University","biomarkers":" CASP3 • ANXA5","pipe":"","alterations":" ","tags":["CASP3 • ANXA5"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • Tazverik (tazemetostat)"],"overall_status":"Recruiting","enrollment":" Enrollment 24","initiation":"Initiation: 08/28/2023","start_date":" 08/28/2023","primary_txt":" Primary completion: 01/01/2026","primary_completion_date":" 01/01/2026","study_txt":" Completion: 01/01/2026","study_completion_date":" 01/01/2026","last_update_posted":"2024-01-05"},{"id":"9263296a-f501-4dcf-9d13-ddd3f6920a7f","acronym":"","url":"https://clinicaltrials.gov/study/NCT05320380","created_at":"2023-08-14T10:11:08.231Z","updated_at":"2024-07-02T16:35:38.286Z","phase":"Phase 1/2","brief_title":"A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat","source_id_and_acronym":"NCT05320380","lead_sponsor":"Children's Oncology Group","biomarkers":" IL3RA","pipe":" | ","alterations":" CD123 positive • IL3RA positive","tags":["IL3RA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e CD123 positive • IL3RA positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e methotrexate • Vyxeos (cytarabine/daunorubicin liposomal formulation) • fludarabine IV • pivekimab sunirine (PVEK) • Starasid (cytarabine ocfosfate)"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 08/01/2023","start_date":" 08/01/2023","primary_txt":" Primary completion: 09/01/2023","primary_completion_date":" 09/01/2023","study_txt":" Completion: 09/01/2023","study_completion_date":" 09/01/2023","last_update_posted":"2023-09-01"},{"id":"8b2804e8-60bc-4a10-b758-708f1c1c2065","acronym":"GFM-CPX MDS","url":"https://clinicaltrials.gov/study/NCT04273802","created_at":"2021-01-18T20:45:32.651Z","updated_at":"2024-07-02T16:36:07.662Z","phase":"Phase 1/2","brief_title":"CPX-351 in Higher Risk Myelodysplastic Syndromes","source_id_and_acronym":"NCT04273802 - GFM-CPX MDS","lead_sponsor":"Groupe Francophone des Myelodysplasies","biomarkers":" FLT3","pipe":"","alterations":" ","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Vyxeos (cytarabine/daunorubicin liposomal formulation)"],"overall_status":"Completed","enrollment":" Enrollment 40","initiation":"Initiation: 04/29/2020","start_date":" 04/29/2020","primary_txt":" Primary completion: 08/27/2021","primary_completion_date":" 08/27/2021","study_txt":" Completion: 07/06/2022","study_completion_date":" 07/06/2022","last_update_posted":"2022-07-07"},{"id":"ce98ee02-21d8-47cc-adbf-beb7c12bd1ab","acronym":"","url":"https://clinicaltrials.gov/study/NCT03760445","created_at":"2021-01-18T18:28:53.713Z","updated_at":"2024-07-02T16:36:51.542Z","phase":"Phase 1/2","brief_title":"HDM201 Added to CT in R/R or Newly Diagnosed AML","source_id_and_acronym":"NCT03760445","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" FLT3 • PML","pipe":" | ","alterations":" FLT3 mutation","tags":["FLT3 • PML"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e midostaurin • Vyxeos (cytarabine/daunorubicin liposomal formulation) • idarubicin hydrochloride • siremadlin (HDM201) • Noxafil (posaconazole) • midazolam hydrochloride"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 11/15/2019","start_date":" 11/15/2019","primary_txt":" Primary completion: 07/22/2021","primary_completion_date":" 07/22/2021","study_txt":" Completion: 06/13/2023","study_completion_date":" 06/13/2023","last_update_posted":"2020-01-09"}]