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Clinical trial · no report yet · Phase 2/Phase 3

NCT03013998

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

We haven't built an HCP commentary report on NCT03013998 yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Indexed commentary on NCT03013998 so far

Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.

ChannelIndexed
X threads3

The trial

ClinicalTrials.gov
Official title
A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)
Phase
Phase 2/Phase 3
Status
Recruiting
Conditions
Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
Interventions
Samalizumab (BAML-16-001-S1); BI 836858 (BAML-16-001-S2); Laboratory Biomarker Analysis; Daunorubicin (BAML-16-001-S1); Cytarabine (BAML-16-001-S1); Azacitidine (BAML-16-001-S2); AG-221 (BAML-16-001-S3); Azacitidine (BAML-16-001-S3); Entospletinib (BAML-16-001-S4); Azacitidine (BAML-16-001-S4); Entospletinib (BAML-16-001-S5); Decitabine (BAML-16-001-S5); Entospletinib (BAML-16-001-S6); Daunorubicin (BAML-16-001-S6); Cytarabine (BAML-16-001-S6); Pevonedistat (BAML-16-001-S9); Azacitidine (BAML-16-001-S9); AG-120 (BAML-16-001-S16); Azacitidine (BAML-16-001-S16); Gilteritinib (BAML-16-001-S8 Group 1); Decitabine (BAML-16-001-S8 Group 1); AZD5153 (BAML-16-001-S10); Venetoclax (BAML-16-001-S10); TP-0903 (BAML-16-001-S14); Decitabine (BAML-16-001-S14); Decitabine (BAML-16-001-S8 Group 2); Venetoclax (BAML-16-001-S8 Group 2); AZD5991 (BAML-16-001-S18); Azacitidine (BAML-16-001-S18); SNDX-5613 (BAML-16-001-S17); Azacitidine (BAML-16-001-S17); Venetoclax (BAML-16-001-S17); Gilteritinib (BAML-16-001-S8 Group 2); Venetoclax (BAML-16-001-S12 Arm A); Azacitidine (BAML-16-001-S12 Arm A); Venetoclax (BAML-16-001-S12 Arm B); Azacitidine (BAML-16-001-S12 Arm B); ZE46-0134 (BAML-16-001-S21 Group 1); ficlatuzumab (BAML-16-001-S24); Azacitidine (BAML-16-001-S24); Venetoclax (BAML-16-001-S24); ZE46-0134 (BAML-16-001-S21 Group 2); Bleximenib (BAML-16-001-S25/HO181); Cytarabine (BAML-16-001-S25/HO181); Daunorubicin or Idarubicin (BAML-16-001-S25/HO181); Placebo (BAML-16-001-S25/HO181); Revumenib (BAML-16-001-S26/HO177); Placebo (BAML-16-001-S26/HO177)
Arms
  • BAML-16-001-S17 · Experimental
  • BAML-16-001-S12, Arm A (Closed) · Active comparator
  • BAML-16-001-S12, Arm B (Closed) · Experimental
  • BAML-16-001-S21, Group 1 (Closed) · Experimental
  • BAML-16-001-S21, Group 2 (Closed) · Experimental
  • BAML-16-001-S24 · Experimental
  • BAML-16-001-S1 (Closed) · Experimental
  • BAML-16-001-S2 (Closed) · Experimental
  • BAML-16-001-S3 (Closed) · Experimental
  • BAML-16-001-S4 (Closed) · Experimental
  • BAML-16-001-S5 (Closed) · Experimental
  • BAML-16-001-S6 (Closed) · Experimental
  • BAML-16-001-S8 (Closed) · Experimental
  • BAML-16-001-S9 (Closed) · Experimental
  • BAML-16-001-S10 (Closed) · Experimental
  • BAML-16-001-S14 (Closed) · Experimental
  • BAML-16-001-S16 (Closed) · Experimental
  • BAML-16-001-S18 (Closed) · Experimental
  • S25/HO181 (Arm 1): Std of care treatment plus bleximenib and also maintenance treatment w/bleximenib · Experimental
  • S25/HO181 (Arm 2): Standard of care treatment plus bleximenib and maintenance treatment w/ a placebo · Experimental
  • S25/HO181 (Arm 3): Standard of care treatment plus a placebo and maintenance treatment w/ a placebo · Placebo comparator
  • BAML-16-001-S26/HO177 (Revumenib-placebo) · Placebo comparator
  • BAML-16-001-S26/HO177 (Revumenib) · Experimental
Enrollment
3,000 (estimated)
Primary outcomes
  • BAML-16-001-M1: Proportion of patients for whom molecular, immunophenotypic, and/or biochemical studies are completed in < 7 calendar days for assignment of treatment
  • BAML-16-001-M1: Proportion of patients assigned to a novel therapeutic treatment group in 1 of several sub-studies in this Master Protocol, based on the result of the molecular, immunophenotypic, and/or biochemical studies
  • BAML-16-001-M1: Clinical response rate (rate of complete and partial responses) according to European Leukemianet (ELN) criteria for treatment outcomes in substudies in acute myeloid leukemia.
  • BAML-16-001-S25/HO181: Event-Free Survival (EFS) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy
  • BAML-16-001-S26/HO177: Overall survival (OS) in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy.
  • BAML-16-001-S26/HO177: Rate of CR in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy
Sponsor
Beat AML, LLC with Syndax Pharmaceuticals, Stichting Hemato-Oncologie voor Volwassenen Nederland, AVEO Pharmaceuticals, Inc.
Start
Nov 2016
Primary completion
Dec 2032 (estimated)
Results posted
No
Registry record
NCT03013998 · updated Sep 3, 2026

Publications

linked from the registry
  • Borate UM, Huang Y, Lin TL, Handa S, Swords R, Lachowiez CA, Traer E, Stock W, Odenike O, Patel AA, Baer MR, Duong VH, Stein EM, Blum W, Vale CA, Curran E, Madanat YF, Olin RL, Schiller GJ, Nichols AD, Williams L, Heerema NA, Johnson MF, Chen TL, Marcus S, Martycz M, Stefanos M, Rosenberg L, DeGennaro LJ, Gruenbaum L, Burd A, Byrd JC, Druker BJ, Levine RL, Yocum AO, Mims AS, Zeidner JF. OPTI-AML: Prospective Comparison of 28 vs.14 days of Venetoclax Induction with Azacitidine in Older Adults with AML. Blood. 2026 Jul 28:blood.2026034611. doi: 10.1182/blood.2026034611. Online ahead of print. PubMed 42520193
  • Dohner H, DiNardo CD, Appelbaum FR, Craddock C, Dombret H, Ebert BL, Fenaux P, Godley LA, Hasserjian RP, Larson RA, Levine RL, Miyazaki Y, Niederwieser D, Ossenkoppele G, Rollig C, Sierra J, Stein EM, Tallman MS, Tien HF, Wang J, Wierzbowska A, Wei AH, Lowenberg B. Genetic risk classification for adults with AML receiving less-intensive therapies: the 2024 ELN recommendations. Blood. 2024 Nov 21;144(21):2169-2173. doi: 10.1182/blood.2024025409. PubMed 39133932
  • Burd A, Levine RL, Ruppert AS, Mims AS, Borate U, Stein EM, Patel P, Baer MR, Stock W, Deininger M, Blum W, Schiller G, Olin R, Litzow M, Foran J, Lin TL, Ball B, Boyiadzis M, Traer E, Odenike O, Arellano M, Walker A, Duong VH, Kovacsovics T, Collins R, Shoben AB, Heerema NA, Foster MC, Vergilio JA, Brennan T, Vietz C, Severson E, Miller M, Rosenberg L, Marcus S, Yocum A, Chen T, Stefanos M, Druker B, Byrd JC. Precision medicine treatment in acute myeloid leukemia using prospective genomic profiling: feasibility and preliminary efficacy of the Beat AML Master Trial. Nat Med. 2020 Dec;26(12):1852-1858. doi: 10.1038/s41591-020-1089-8. Epub 2020 Oct 26. PubMed 33106665
  • Borate U, Yang F, Press R, Ruppert AS, Jones D, Caruthers S, Zhao W, Vergilio JA, Pavlick DC, Juckett L, Norris B, Bucy T, Burd A, Stein EM, Patel P, Baer MR, Stock W, Schiller G, Blum W, Kovacsovics T, Litzow M, Foran J, Heerema NA, Rosenberg L, Marcus S, Yocum A, Stefanos M, Druker B, Byrd JC, Levine RL, Mims A. Samples from patients with AML show high concordance in detection of mutations by NGS at local institutions vs central laboratories. Blood Adv. 2023 Oct 24;7(20):6048-6054. doi: 10.1182/bloodadvances.2022009008. PubMed 37459200
  • Rosenberg L, Levaux H, Levine RL, Shah A, Denmark J, Hereema N, Owen M, Kalk S, Kenny N, Vinson G, Vergilio JA, Mims A, Borate U, Blum W, Stein E, Gana TJ, Stefanos M, Yocum A, Marcus S, Shoben A, Druker B, Byrd J, Burd A. Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial. Ther Innov Regul Sci. 2021 Sep;55(5):926-935. doi: 10.1007/s43441-021-00277-w. Epub 2021 May 16. PubMed 33997942
  • Cai SF, Huang Y, Lance JR, Mao HC, Dunbar AJ, McNulty SN, Druley T, Li Y, Baer MR, Stock W, Kovacsovics T, Blum WG, Schiller GJ, Olin RL, Foran JM, Litzow M, Lin T, Patel P, Foster MC, Boyiadzis M, Collins RH, Chervin J, Shoben A, Vergilio JA, Heerema NA, Rosenberg L, Chen TL, Yocum AO, Druggan F, Marcus S, Stefanos M, Druker BJ, Mims AS, Borate U, Burd A, Byrd JC, Levine RL, Stein EM. A study to assess the efficacy of enasidenib and risk-adapted addition of azacitidine in newly diagnosed IDH2-mutant AML. Blood Adv. 2024 Jan 23;8(2):429-440. doi: 10.1182/bloodadvances.2023010563. PubMed 37871309
  • Duong VH, Ruppert AS, Mims AS, Borate U, Stein EM, Baer MR, Stock W, Kovacsovics T, Blum W, Arellano ML, Schiller GJ, Olin RL, Foran JM, Litzow MR, Lin TL, Patel PA, Foster MC, Redner RL, Al-Mansour Z, Cogle CR, Swords RT, Collins RH, Vergilio JA, Heerema NA, Rosenberg L, Yocum AO, Marcus S, Chen T, Druggan F, Stefanos M, Gana TJ, Shoben AB, Druker BJ, Burd A, Byrd JC, Levine RL, Boyiadzis MM. Entospletinib with decitabine in acute myeloid leukemia with mutant TP53 or complex karyotype: A phase 2 substudy of the Beat AML Master Trial. Cancer. 2023 Aug 1;129(15):2308-2320. doi: 10.1002/cncr.34780. Epub 2023 Apr 20. PubMed 37078412
  • Saliba AN, Kaufmann SH, Stein EM, Patel PA, Baer MR, Stock W, Deininger M, Blum W, Schiller GJ, Olin RL, Litzow MR, Lin TL, Ball BJ, Boyiadzis MM, Traer E, Odenike O, Arellano ML, Walker A, Duong VH, Kovacsovics T, Collins RH, Shoben AB, Heerema NA, Foster MC, Peterson KL, Schneider PA, Martycz M, Gana TJ, Rosenberg L, Marcus S, Yocum AO, Chen T, Stefanos M, Mims AS, Borate U, Burd A, Druker BJ, Levine RL, Byrd JC, Foran JM. Pevonedistat with azacitidine in older patients with TP53-mutated AML: a phase 2 study with laboratory correlates. Blood Adv. 2023 Jun 13;7(11):2360-2363. doi: 10.1182/bloodadvances.2022008625. No abstract available. PubMed 36315007
  • Eisenmann ED, Swords R, Huang Y, Orwick S, Buelow D, Abbott N, Phelps M, Zeidner J, Foster MC, Lin TL, Baer MR, Madanat YF, Kovacsovics T, Redner R, Al-Mansour Z, Bhatnagar B, Stefanos M, Martycz M, Druggan F, Chen TL, Yocum AO, Borate U, Druker BJ, Burd A, Levine RL, Byrd JC, Baker SD, Mims AS. A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant TP53 and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia >/=Age 60 Years. Cancer Res Commun. 2025 Jul 1;5(7):1129-1139. doi: 10.1158/2767-9764.CRC-25-0091. PubMed 40557912
  • Zeidner JF, Lin TL, Welkie RL, Curran E, Koenig K, Stock W, Madanat YF, Swords R, Baer MR, Blum W, Stein EM, Olin RL, Schiller G, Nichols A, Odenike O, Traer E, Lachowiez C, Duong VH, Hochman MJ, Cai SF, Smith C, Stefanos M, Martycz M, Huang Y, Rosenberg L, Marcus S, Chen TL, Yocum AO, Druker BJ, Levine RL, Borate U, Byrd JC, Mims AS. Azacitidine, Venetoclax, and Revumenib for Newly Diagnosed NPM1-Mutated or KMT2A-Rearranged AML. J Clin Oncol. 2025 Aug 10;43(23):2606-2615. doi: 10.1200/JCO-25-00914. Epub 2025 Jun 12. PubMed 40504618
Analysis of public HCP commentary. Not medical advice and not for promotional use. Reports do not judge efficacy, estimate consensus or promote any product.
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