{"commentary":{"count":94,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":37,"podcast":30,"x_thread":26,"x_video":1},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04065399\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"AUGMENT-101","nct_id":"NCT04065399","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=augment-101-nct04065399. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"AUGMENT-101","arms":[{"description":"Phase 1: Oral revumenib; sequential cohorts of escalating dose levels of revumenib. Participants will be enrolled in 1 of 6 dose-escalation arms:\n\n* Arm A: Participants not receiving any strong CYP3A4 inhibitor/inducers or fluconazole\n* Arm B: Participants receiving any strong CYP3A4 inhibitors for antifungal prophylaxis\n* Arm C: Participants receiving revumenib and cobicistat\n* Arm D: Participants receiving fluconazole for antifungal prophylaxis\n* Arm E: Participants not receiving any weak, moderate, or strong CYP3A4 inhibitors/inducers\n* Arm F: Participants receiving isavuconazole for antifungal prophylaxis\n\nPhase 2: Oral revumenib; 4 indication-specific expansion cohorts will be enrolled:\n\n* Cohort 2A: Participants with KMT2Ar ALL/MPAL\n* Cohort 2B: Participants with KMT2Ar AML\n* Cohort 2C: Participants with NPM1m AML\n* Cohort 2D: Participants with acute leukemia (including KMT2Ar, NPM1m, NUP98r and other acute leukemias expected to have HOX/MEIS upregulation)","label":"Revumenib","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-12-15","type":"ESTIMATED"},"conditions":["Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Mixed Lineage Acute Leukemia","Mixed Phenotype Acute Leukemia","Acute Leukemia of Ambiguous Lineage"],"enrollment":{"count":447,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"revumenib","type":"DRUG"},{"name":"cobicistat","type":"DRUG"}],"last_update":"2026-10-09","lead_sponsor":"Syndax Pharmaceuticals","official_title":"A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-12-15","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Number of participants with dose-limiting toxicities (DLTs) (Phase 1)","timeFrame":"Approximately 1 year"},{"measure":"Number of participants with treatment-emergent adverse events (TEAEs) (Phase 1)","timeFrame":"Approximately 1 year"},{"measure":"Cmax (Phase 1)","timeFrame":"Approximately 1 year"},{"measure":"Tmax (Phase 1)","timeFrame":"Approximately 1 year"},{"measure":"AUC0-t (Phase 1)","timeFrame":"Approximately 1 year"},{"measure":"CR+CRh rate (Phase 2 [Cohorts 2A-2C])","timeFrame":"Approximately 3 years"},{"measure":"Number of participants with TEAEs (Phase 2 [Cohorts 2A-2C])","timeFrame":"Approximately 3 years"},{"measure":"Cmax (Phase 2 [Cohort 2D])","timeFrame":"Approximately 3 years"},{"measure":"AUC0-tau (Phase 2 [Cohort 2D])","timeFrame":"Approximately 3 years"}],"references":[{"citation":"Garcia MB, Wang B, Sheikh I, El Hajjar G, McCall D, Nunez C, Gibson A, Lorenzi PL, Issa GC, Cuglievan B, Abbas HA. High-Throughput Proteomic Profiling to Evaluate Differentiation Syndrome With Menin Inhibition. Mol Cell Proteomics. 2026 Mar;25(3):101522. doi: 10.1016/j.mcpro.2026.101522. Epub 2026 Jan 30.","pmid":"41621809","type":"DERIVED"},{"citation":"Arellano ML, Thirman MJ, DiPersio JF, Heiblig M, Stein EM, Schuh AC, Zucenka A, de Botton S, Grove CS, Mannis GN, Papayannidis C, Perl AE, Issa GC, Aldoss I, Bajel A, Dickens DS, Kuhn MWM, Mantzaris I, Raffoux E, Traer E, Amitai I, Dohner H, Greco C, Kovacsovics T, McMahon CM, Montesinos P, Pigneux A, Shami PJ, Stone RM, Wolach O, Harpel JG, Chudnovsky Y, Yu L, Bagley RG, Smith AR, Blachly JS. Menin inhibition with revumenib for NPM1-mutated relapsed or refractory acute myeloid leukemia: the AUGMENT-101 study. Blood. 2025 Aug 28;146(9):1065-1077. doi: 10.1182/blood.2025028357.","pmid":"40332046","type":"DERIVED"},{"citation":"Issa GC, Aldoss I, Thirman MJ, DiPersio J, Arellano M, Blachly JS, Mannis GN, Perl A, Dickens DS, McMahon CM, Traer E, Zwaan CM, Grove CS, Stone R, Shami PJ, Mantzaris I, Greenwood M, Shukla N, Cuglievan B, Kovacsovics T, Gu Y, Bagley RG, Madigan K, Chudnovsky Y, Nguyen HV, McNeer N, Stein EM. Menin Inhibition With Revumenib for KMT2A-Rearranged Relapsed or Refractory Acute Leukemia (AUGMENT-101). J Clin Oncol. 2025 Jan;43(1):75-84. doi: 10.1200/JCO.24.00826. Epub 2024 Aug 9.","pmid":"39121437","type":"DERIVED"},{"citation":"Issa GC, Aldoss I, DiPersio J, Cuglievan B, Stone R, Arellano M, Thirman MJ, Patel MR, Dickens DS, Shenoy S, Shukla N, Kantarjian H, Armstrong SA, Perner F, Perry JA, Rosen G, Bagley RG, Meyers ML, Ordentlich P, Gu Y, Kumar V, Smith S, McGeehan GM, Stein EM. The menin inhibitor revumenib in KMT2A-rearranged or NPM1-mutant leukaemia. Nature. 2023 Mar;615(7954):920-924. doi: 10.1038/s41586-023-05812-3. Epub 2023 Mar 15.","pmid":"36922593","type":"DERIVED"},{"citation":"Sasca D, Guezguez B, Kuhn MWM. Next generation epigenetic modulators to target myeloid neoplasms. Curr Opin Hematol. 2021 Sep 1;28(5):356-363. doi: 10.1097/MOH.0000000000000673.","pmid":"34267079","type":"DERIVED"},{"citation":"Jimenez JA, Apfelbaum AA, Hawkins AG, Svoboda LK, Kumar A, Ruiz RO, Garcia AX, Haarer E, Nwosu ZC, Bradin J, Purohit T, Chen D, Cierpicki T, Grembecka J, Lyssiotis CA, Lawlor ER. EWS-FLI1 and Menin Converge to Regulate ATF4 Activity in Ewing Sarcoma. Mol Cancer Res. 2021 Jul;19(7):1182-1195. doi: 10.1158/1541-7786.MCR-20-0679. Epub 2021 Mar 19.","pmid":"33741715","type":"DERIVED"}],"start_date":{"date":"2019-11-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation","url":"https://clinicaltrials.gov/study/NCT04065399"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/augment-101-nct04065399"}