[{"id":"ee6272e6-f952-43d3-a46c-9401133eded9","acronym":"","url":"https://clinicaltrials.gov/study/NCT07007312","created_at":"2025-06-07T14:39:25.624Z","updated_at":"2025-06-07T14:39:25.624Z","phase":"Phase 3","brief_title":"Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML","source_id_and_acronym":"NCT07007312","lead_sponsor":"Kura Oncology, Inc.","biomarkers":" NPM1","pipe":"","alterations":" ","tags":["NPM1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • cytarabine • daunorubicin • Komzifti (ziftomenib)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 1300","initiation":"Initiation: 09/01/2025","start_date":" 09/01/2025","primary_txt":" Primary completion: 11/01/2031","primary_completion_date":" 11/01/2031","study_txt":" Completion: 11/01/2031","study_completion_date":" 11/01/2031","last_update_posted":"2025-06-05"},{"id":"c2fb4b7e-7e4c-490d-87bd-2814f4996b26","acronym":"","url":"https://clinicaltrials.gov/study/NCT05886049","created_at":"2023-06-02T14:06:05.454Z","updated_at":"2025-02-25T13:55:14.969Z","phase":"Phase 1","brief_title":"Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene","source_id_and_acronym":"NCT05886049","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" FLT3 • NPM1 • KMT2A","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3 mutation • NPM1 mutation • MLL mutation","tags":["FLT3 • NPM1 • KMT2A"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3 mutation • NPM1 mutation • MLL mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e daunorubicin • Revuforj (revumenib) • Starasid (cytarabine ocfosfate)"],"overall_status":"Recruiting","enrollment":" Enrollment 28","initiation":"Initiation: 06/20/2024","start_date":" 06/20/2024","primary_txt":" Primary completion: 12/31/2027","primary_completion_date":" 12/31/2027","study_txt":" Completion: 12/31/2027","study_completion_date":" 12/31/2027","last_update_posted":"2025-02-20"},{"id":"2215a379-2b74-4e43-b073-534f2995d428","acronym":"","url":"https://clinicaltrials.gov/study/NCT06001788","created_at":"2023-08-21T14:08:48.344Z","updated_at":"2025-02-25T15:13:42.778Z","phase":"Phase 1","brief_title":"Safety and Tolerability of Ziftomenib Combinations in Patients with Relapsed/Refractory Acute Myeloid Leukemia","source_id_and_acronym":"NCT06001788","lead_sponsor":"Kura Oncology, Inc.","biomarkers":" FLT3 • NPM1 • KMT2A","pipe":" | ","alterations":" FLT3 mutation • NPM1 mutation • KMT2A rearrangement • KMT2A mutation • MLL mutation","tags":["FLT3 • NPM1 • KMT2A"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3 mutation • NPM1 mutation • KMT2A rearrangement • KMT2A mutation • MLL mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • Xospata (gilteritinib) • idarubicin hydrochloride • Komzifti (ziftomenib) • fludarabine IV"],"overall_status":"Recruiting","enrollment":" Enrollment 171","initiation":"Initiation: 02/22/2024","start_date":" 02/22/2024","primary_txt":" Primary completion: 08/01/2026","primary_completion_date":" 08/01/2026","study_txt":" Completion: 08/01/2027","study_completion_date":" 08/01/2027","last_update_posted":"2025-02-13"},{"id":"96dc9fc0-af06-4f1e-b4e5-802d917774dd","acronym":"","url":"https://clinicaltrials.gov/study/NCT05761171","created_at":"2023-03-09T15:01:28.014Z","updated_at":"2025-02-25T15:13:22.304Z","phase":"Phase 2","brief_title":"A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia","source_id_and_acronym":"NCT05761171","lead_sponsor":"Children's Oncology Group","biomarkers":" KMT2A","pipe":" | ","alterations":" MLL rearrangement","tags":["KMT2A"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MLL rearrangement"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • methotrexate • vincristine • Revuforj (revumenib) • Oncaspar liquid (pegaspargase) • fludarabine IV • Asparlas (calaspargase pegol-mknl) • Starasid (cytarabine ocfosfate)"],"overall_status":"Recruiting","enrollment":" Enrollment 78","initiation":"Initiation: 01/08/2024","start_date":" 01/08/2024","primary_txt":" Primary completion: 12/31/2027","primary_completion_date":" 12/31/2027","study_txt":" Completion: 12/31/2027","study_completion_date":" 12/31/2027","last_update_posted":"2025-02-13"},{"id":"facf7f83-63bf-49f3-a6fb-2b75c0782dba","acronym":"","url":"https://clinicaltrials.gov/study/NCT05848687","created_at":"2023-05-08T15:04:02.177Z","updated_at":"2025-02-25T17:26:10.730Z","phase":"Phase 1/2","brief_title":"TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II","source_id_and_acronym":"NCT05848687","lead_sponsor":"Tanja Andrea Gruber","biomarkers":" KMT2A","pipe":" | ","alterations":" CD19 positive","tags":["KMT2A"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e CD19 positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bortezomib • Blincyto (blinatumomab) • Zolinza (vorinostat) • dexamethasone • mitoxantrone • Komzifti (ziftomenib) • mercaptopurine"],"overall_status":"Recruiting","enrollment":" Enrollment 90","initiation":"Initiation: 11/03/2023","start_date":" 11/03/2023","primary_txt":" Primary completion: 12/01/2028","primary_completion_date":" 12/01/2028","study_txt":" Completion: 12/01/2033","study_completion_date":" 12/01/2033","last_update_posted":"2025-01-31"},{"id":"a188d51f-518e-489f-ab1d-5187bf693db5","acronym":"","url":"https://clinicaltrials.gov/study/NCT05918913","created_at":"2023-06-26T14:09:16.870Z","updated_at":"2025-02-25T15:45:09.016Z","phase":"","brief_title":"Expanded Access Program for Revumenib","source_id_and_acronym":"NCT05918913","lead_sponsor":"Syndax Pharmaceuticals","biomarkers":" NPM1 • NUP98","pipe":" | ","alterations":" NPM1 mutation","tags":["NPM1 • NUP98"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e NPM1 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Revuforj (revumenib)"],"overall_status":"Available","enrollment":"","initiation":"","start_date":"","primary_txt":"","primary_completion_date":"","study_txt":"","study_completion_date":"","last_update_posted":"2025-01-10"},{"id":"405c722c-6da5-4af1-ae5c-65ee9d9b67ac","acronym":"","url":"https://clinicaltrials.gov/study/NCT06746519","created_at":"2025-02-26T08:20:50.749Z","updated_at":"2025-02-26T08:20:50.749Z","phase":"Phase 1/2","brief_title":"BN104 in Combination With Chemotherapy or Targeted Agents for Acute Myeloid Leukemia","source_id_and_acronym":"NCT06746519","lead_sponsor":"Chen Suning","biomarkers":" HOXA9 • MEIS1","pipe":"","alterations":" ","tags":["HOXA9 • MEIS1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • azacitidine"],"overall_status":"Recruiting","enrollment":" Enrollment 135","initiation":"Initiation: 12/25/2024","start_date":" 12/25/2024","primary_txt":" Primary completion: 12/30/2025","primary_completion_date":" 12/30/2025","study_txt":" Completion: 06/30/2027","study_completion_date":" 06/30/2027","last_update_posted":"2024-12-24"},{"id":"ed5105cc-c09f-44e6-909c-68846cffde3b","acronym":"","url":"https://clinicaltrials.gov/study/NCT06652438","created_at":"2025-02-26T15:12:55.434Z","updated_at":"2025-02-26T15:12:55.434Z","phase":"Phase 3","brief_title":"Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML","source_id_and_acronym":"NCT06652438","lead_sponsor":"Stichting Hemato-Oncologie voor Volwassenen Nederland","biomarkers":" NPM1","pipe":" | ","alterations":" NPM1 mutation","tags":["NPM1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e NPM1 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • azacitidine • Revuforj (revumenib)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 415","initiation":"Initiation: 02/13/2025","start_date":" 02/13/2025","primary_txt":" Primary completion: 05/13/2028","primary_completion_date":" 05/13/2028","study_txt":" Completion: 05/31/2031","study_completion_date":" 05/31/2031","last_update_posted":"2024-10-30"},{"id":"66017a7e-e1f3-43a3-a59a-3c773b2ee231","acronym":"AUGMENT-101","url":"https://clinicaltrials.gov/study/NCT04065399","created_at":"2021-01-18T19:55:07.775Z","updated_at":"2024-07-02T16:35:03.156Z","phase":"Phase 1/2","brief_title":"A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation","source_id_and_acronym":"NCT04065399 - AUGMENT-101","lead_sponsor":"Syndax Pharmaceuticals","biomarkers":" KMT2A • NUP98","pipe":" | ","alterations":" NPM1 mutation • MLL rearrangement • MLL rearrangement • NUP98 rearrangement","tags":["KMT2A • NUP98"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e NPM1 mutation • MLL rearrangement • MLL rearrangement • NUP98 rearrangement"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Revuforj (revumenib) • Tybost (cobicistat)"],"overall_status":"Recruiting","enrollment":" Enrollment 413","initiation":"Initiation: 11/05/2019","start_date":" 11/05/2019","primary_txt":" Primary completion: 12/01/2024","primary_completion_date":" 12/01/2024","study_txt":" Completion: 12/01/2024","study_completion_date":" 12/01/2024","last_update_posted":"2024-05-17"},{"id":"effe32d4-632d-47ed-9569-8f5ee71685a3","acronym":"","url":"https://clinicaltrials.gov/study/NCT05326516","created_at":"2022-04-13T11:55:14.906Z","updated_at":"2024-07-02T16:35:02.858Z","phase":"Phase 1","brief_title":"A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia","source_id_and_acronym":"NCT05326516","lead_sponsor":"Syndax Pharmaceuticals","biomarkers":" KMT2A • NUP98","pipe":" | ","alterations":" KMT2A rearrangement • MLL rearrangement","tags":["KMT2A • NUP98"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e KMT2A rearrangement • MLL rearrangement"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • cyclophosphamide • Revuforj (revumenib)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 30","initiation":"Initiation: 03/09/2022","start_date":" 03/09/2022","primary_txt":" Primary completion: 05/01/2024","primary_completion_date":" 05/01/2024","study_txt":" Completion: 06/01/2024","study_completion_date":" 06/01/2024","last_update_posted":"2024-05-17"},{"id":"c62a7f73-b1c2-406a-b3bd-f74ccdc4bd18","acronym":"KOMET-007","url":"https://clinicaltrials.gov/study/NCT05735184","created_at":"2023-02-21T16:01:44.880Z","updated_at":"2024-07-02T16:35:03.357Z","phase":"Phase 1","brief_title":"A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, or 7+3 in Patients With AML","source_id_and_acronym":"NCT05735184 - KOMET-007","lead_sponsor":"Kura Oncology, Inc.","biomarkers":" NPM1 • KMT2A","pipe":" | ","alterations":" NPM1 mutation • KMT2A rearrangement • MLL rearrangement • KMT2A mutation • MLL mutation","tags":["NPM1 • KMT2A"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e NPM1 mutation • KMT2A rearrangement • MLL rearrangement • KMT2A mutation • MLL mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • azacitidine • daunorubicin • Komzifti (ziftomenib)"],"overall_status":"Recruiting","enrollment":" Enrollment 212","initiation":"Initiation: 07/18/2023","start_date":" 07/18/2023","primary_txt":" Primary completion: 05/01/2026","primary_completion_date":" 05/01/2026","study_txt":" Completion: 05/01/2027","study_completion_date":" 05/01/2027","last_update_posted":"2024-05-16"},{"id":"46a5415c-22f8-4ee5-9a6c-fe01bd492c0b","acronym":"","url":"https://clinicaltrials.gov/study/NCT06387082","created_at":"2024-04-26T14:50:27.501Z","updated_at":"2024-07-02T16:35:07.392Z","phase":"Phase 1","brief_title":"A Clinical Study of HMPL-506 in Patients With Hematological Malignancies","source_id_and_acronym":"NCT06387082","lead_sponsor":"Hutchmed","biomarkers":" HOXA9 • ITGAM","pipe":"","alterations":" ","tags":["HOXA9 • ITGAM"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 98","initiation":"Initiation: 05/09/2024","start_date":" 05/09/2024","primary_txt":" Primary completion: 10/08/2027","primary_completion_date":" 10/08/2027","study_txt":" Completion: 12/08/2027","study_completion_date":" 12/08/2027","last_update_posted":"2024-04-26"},{"id":"6920805f-47cc-46c1-9b7c-1cf720663501","acronym":"KOMET-001","url":"https://clinicaltrials.gov/study/NCT04067336","created_at":"2021-01-17T17:22:51.063Z","updated_at":"2024-07-02T16:35:14.761Z","phase":"Phase 1/2","brief_title":"First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia","source_id_and_acronym":"NCT04067336 - KOMET-001","lead_sponsor":"Kura Oncology, Inc.","biomarkers":" NPM1 • KMT2A","pipe":" | ","alterations":" NPM1 mutation • KMT2A rearrangement","tags":["NPM1 • KMT2A"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e NPM1 mutation • KMT2A rearrangement"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Komzifti (ziftomenib)"],"overall_status":"Recruiting","enrollment":" Enrollment 199","initiation":"Initiation: 09/12/2019","start_date":" 09/12/2019","primary_txt":" Primary completion: 09/30/2024","primary_completion_date":" 09/30/2024","study_txt":" Completion: 09/30/2025","study_completion_date":" 09/30/2025","last_update_posted":"2024-03-15"},{"id":"6c05718b-8a7f-4a20-bf78-b51f8a8735e2","acronym":"","url":"https://clinicaltrials.gov/study/NCT06052813","created_at":"2023-09-25T14:10:32.555Z","updated_at":"2024-07-02T16:35:18.364Z","phase":"Phase 1/2","brief_title":"A Study of BN104 in the Treatment of Acute Leukemia","source_id_and_acronym":"NCT06052813","lead_sponsor":"BioNova Pharmaceuticals (Shanghai) LTD.","biomarkers":" NPM1 • KMT2A","pipe":" | ","alterations":" NPM1 mutation • KMT2A rearrangement • MLL rearrangement • KMT2A mutation • MLL mutation","tags":["NPM1 • KMT2A"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e NPM1 mutation • KMT2A rearrangement • MLL rearrangement • KMT2A mutation • MLL mutation"],"overall_status":"Recruiting","enrollment":" Enrollment 90","initiation":"Initiation: 09/16/2023","start_date":" 09/16/2023","primary_txt":" Primary completion: 06/01/2026","primary_completion_date":" 06/01/2026","study_txt":" Completion: 06/01/2027","study_completion_date":" 06/01/2027","last_update_posted":"2024-02-21"},{"id":"de421412-fb86-418c-a6aa-0a09654defc6","acronym":"DSP-5336-101","url":"https://clinicaltrials.gov/study/NCT04988555","created_at":"2021-08-03T18:53:07.117Z","updated_at":"2024-07-02T16:35:23.111Z","phase":"Phase 1/2","brief_title":"A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation","source_id_and_acronym":"NCT04988555 - DSP-5336-101","lead_sponsor":"Sumitomo Pharma America, Inc.","biomarkers":" FLT3 • IDH1 • IDH2 • NPM1 • KMT2A","pipe":" | ","alterations":" NPM1 mutation • MLL fusion","tags":["FLT3 • IDH1 • IDH2 • NPM1 • KMT2A"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e NPM1 mutation • MLL fusion"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e enzomenib (DSP-5336) • Noxafil (posaconazole)"],"overall_status":"Recruiting","enrollment":" Enrollment 70","initiation":"Initiation: 02/28/2022","start_date":" 02/28/2022","primary_txt":" Primary completion: 01/02/2025","primary_completion_date":" 01/02/2025","study_txt":" Completion: 02/01/2025","study_completion_date":" 02/01/2025","last_update_posted":"2024-01-18"},{"id":"55adb811-b891-4933-bcb8-86892c74e47f","acronym":"","url":"https://clinicaltrials.gov/study/NCT04752163","created_at":"2021-02-12T13:55:51.280Z","updated_at":"2024-07-02T16:35:29.212Z","phase":"Phase 1/2","brief_title":"DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia","source_id_and_acronym":"NCT04752163","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" FLT3 • NPM1","pipe":" | ","alterations":" NPM1 mutation","tags":["FLT3 • NPM1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e NPM1 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • Rituxan (rituximab) • cytarabine • azacitidine • cyclophosphamide • methotrexate • vincristine • leucovorin calcium • Truxima (rituximab-abbs) • emilumenib succinate (DS-1594) • mesna • Riabni (rituximab-arrx) • Delito (rituximab biosimilar) • GB241 (rituximab biosimilar) • JHL1101 (rituximab biosimilar) • Neupogen (filgrastim) • Novex (rituximab biosimilar) • Noxafil (posaconazole) • Starasid (cytarabine ocfosfate) • cyclophosphamide intravenous"],"overall_status":"Completed","enrollment":" Enrollment 17","initiation":"Initiation: 03/25/2021","start_date":" 03/25/2021","primary_txt":" Primary completion: 11/08/2023","primary_completion_date":" 11/08/2023","study_txt":" Completion: 11/08/2023","study_completion_date":" 11/08/2023","last_update_posted":"2023-11-15"}]