{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"NCT03013998","nct_id":"NCT03013998","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03013998. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"\\*\\*Active, not Recruiting\\*\\* This is an open-label Phase 1b dose escalation followed by dose expansion clinical trial to determine the safety and recommended dose of SNDX-5613 combined with azacitidine and venetoclax in newly diagnosed, untreated AML patients age ≥ 60 years who are not candidates or do not wish to pursue intensive induction therapy and who have NPM1 mutated or KMT2A-rearranged disease.","label":"BAML-16-001-S17","type":"EXPERIMENTAL"},{"description":"This is an open label phase 2 randomized study in which eligible AML patients will be randomly assigned (1:1) to receive either the FDA label-approved regimen of 28-day Venetoclax + Azacitidine (Arm A) or the 14-day regimen of Venetoclax + Azacitidine (Arm B). Newly diagnosed acute myeloid leukemia (AML) patients ≥ 60 years will be enrolled.","label":"BAML-16-001-S12, Arm A (Closed)","type":"ACTIVE_COMPARATOR"},{"description":"This is an open label phase 2 randomized study in which eligible AML patients will be randomly assigned (1:1) to receive either the FDA label-approved regimen of 28-day Venetoclax + Azacitidine (Arm A) or the 14-day regimen of Venetoclax + Azacitidine (Arm B). Newly diagnosed acute myeloid leukemia (AML) patients ≥ 60 years will be enrolled.","label":"BAML-16-001-S12, Arm B (Closed)","type":"EXPERIMENTAL"},{"description":"This is a Phase 1, open-label, multicenter, dose escalation, and dose optimization study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE46-0134 in adult patients with relapsed or refractory AML with FLT3-ITD and/or FLT3-TKD mutations for Group 1 and with spliceosome (SF3B1, SRSF2, U2AFI and ZRSR2) mutations for Group 2. Patients with AML that are out-patients or hospitalized due to their AML can be enrolled in the study. The study will be run in 2 parts: Part 1 will be dose escalation and determination of the maximum tolerated dose, and Part 2 will be dose expansion.","label":"BAML-16-001-S21, Group 1 (Closed)","type":"EXPERIMENTAL"},{"description":"This is a Phase 1, open-label, multicenter, dose escalation, and dose optimization study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE46-0134 in adult patients with relapsed or refractory AML with FLT3-ITD and/or FLT3-TKD mutations for Group 1 and with spliceosome (SF3B1, SRSF2, U2AFI and ZRSR2) mutations for Group 2. Patients with AML that are out-patients or hospitalized due to their AML can be enrolled in the study. The study will be run in 2 parts: Part 1 will be dose escalation and determination of the maximum tolerated dose, and Part 2 will be dose expansion.","label":"BAML-16-001-S21, Group 2 (Closed)","type":"EXPERIMENTAL"},{"description":"\\*\\*Recruiting\\*\\* This is a multi-center open-label Phase 1b safety run-in study followed by a Phase 2 study of ficlatuzumab given in combination with venetoclax azacitidine, in newly diagnosed untreated acute myeloid leukemia age ≥ 60 years who are not candidates or do not wish to pursue intensive induction therapy.","label":"BAML-16-001-S24","type":"EXPERIMENTAL"},{"description":"This is an open-label Phase 1b/2 clinical study of Samalizumab given in addition to standard induction chemotherapy/consolidation, followed by Samalizumab maintenance, in newly diagnosed acute myeloid leukemia. Patients that are marker negative, as defined based on the Beat AML Master Protocol assignment or with CBF karyotype/interphase cytogenetics/molecular testing defined by presence of t(8;21)(q22;q22) or the molecular equivalent RUNX1/RUNX1T1 fusion transcript or inv(16)(p13q22) or t(16;16)(p13;q22) or the molecular equivalent CBFB/MYH11 fusion transcript based on the Beat AML will receive Samalizumab in combination with induction therapy followed by Samalizumab maintenance.","label":"BAML-16-001-S1 (Closed)","type":"EXPERIMENTAL"},{"description":"This is an open-label Phase 1b/2 clinical study of BI 836858 given in combination with azacitidine, followed by BI 836858 plus azacitidine maintenance, in newly diagnosed acute myeloid leukemia. The target population is assigned by the Beat AML Master Protocol (the \"umbrella\" study). Eligible patients will have previously untreated acute myeloid leukemia, age greater than or equal to 60, with any 1 of the following: mutated TET2, IDH1, IDH2, or WT1, or \"marker negative\" as defined by the overall Beat AML umbrella protocol.","label":"BAML-16-001-S2 (Closed)","type":"EXPERIMENTAL"},{"description":"This is a phase 2 clinical trial to assess the feasibility and efficacy of a stepwise approach to the treatment of IDH2-mutant AML. On day 1 of the trial, all enrolled participants will be initiated on therapy with the IDH2 inhibitor AG-221 for IDH2 R140 and R172-mutant patients. The dosing will be based on phase 1 experience of AG-221, which has established 100 mg daily as a safe and tolerated dose, with preliminary suggestion of efficacy. These will be administered continuously in 28 day cycles. Hydroxyurea will be allowed for the purposes of cytoreduction.","label":"BAML-16-001-S3 (Closed)","type":"EXPERIMENTAL"},{"description":"This is a 2 cohort phase 1b/2 clinical trial to assess the feasibility and efficacy of entospletinib (ENTO) stepwise approach to the treatment of patients with balanced translocations of MLL identified cytogenetically (Cohort 1) and patients with MLL-partial tandem duplications identified molecularly (Cohort 2). All enrolled participants will be initiated on monotherapy with ENTO 400 mg PO BID. This dose will be administered continuously in 28 day cycles.","label":"BAML-16-001-S4 (Closed)","type":"EXPERIMENTAL"},{"description":"This is a phase 2 clinical trial to assess the feasibility and efficacy of a stepwise approach to the treatment of patients with TP53 mutations (identified molecularly) with/without complex karyotype (Cohort A) or complex karyotype (3 or greater metaphase abnormalities without TP53) (Cohort B). All enrolled participants will be initiated on entospletinib 400 mg orally twice daily. This dose will be administered continuously in 28 day cycles.","label":"BAML-16-001-S5 (Closed)","type":"EXPERIMENTAL"},{"description":"The study is an open-label phase 2 study of entospletinib in younger and older AML patients with NPM1+/FLT3ITD-AML. It includes patients age ≥18 years who are able and willing to receive 7 + 3 intensive chemotherapy. Entospletinib is administered daily with IV daunorubicin (days 1-3 for Cycle 1) and cytarabine (days 1-7 for Cycle 1). If a second induction is required, it is given with IV daunorubicin (days 1-2 for Cycle 2) and cytarabine (days 1-5 for Cycle 2).","label":"BAML-16-001-S6 (Closed)","type":"EXPERIMENTAL"},{"description":"This is an open-label Phase 1b/2 clinical study of gilteritinib monotherapy, gilteritinib in combination with decitabine, or gilteritinib in combination with decitabine and venetoclax in untreated FLT3 mutated AML with high and low variant allele frequency. Initially, the combination of gilteritinib and decitabine was tested (Group 1); however, subsequently the combination of decitabine and venetoclax was shown to be a highly effective therapy for older AML patients, so the triple combination of gilteritinib in combination with decitabine and venetoclax (Group 2) is now being evaluated in this study.","label":"BAML-16-001-S8 (Closed)","type":"EXPERIMENTAL"},{"description":"This is an open-label phase 2 clinical trial of a stepwise approach to the treatment of patients with TP53 mutation AML. On day 1, all enrolled participants will be initiated on therapy with pevonedistat (20 mg/m2) day 1, 3 and 5 together with azacitidine (75 mg/m2 days 1-7 or day 1-5 then day 8, 9) every 28 days. During cycle 1, patients with rapidly progressive disease or severe organ dysfunction, not correctable by hydroxyurea cytoreduction will not be eligible to continue. Those patients who achieved a response, defined as complete response or complete response with incomplete blood count recovery, by the end of cycle 4 will continue on pevonedistat and azacitidine until disease progression, unacceptable toxicity, or 12 cycles of therapy. After 12 months of combined therapy, pevonedistat will be continued until progression of disease, unacceptable toxicity, or up to 2 years of total therapy.","label":"BAML-16-001-S9 (Closed)","type":"EXPERIMENTAL"},{"description":"This is a phase 1b/2 clinical trial to assess the safety and efficacy of the combination of AZD5153 and venetoclax. In a phase 1b component, safety and tolerability of the combination will be assessed in relapsed/refractory AML patients ≥ 18 years of age. Following determination of the recommended Phase 2 dose (RP2D), newly diagnosed, marker negative patients age ≥ 60 will be enrolled in the phase 2 component; these patients will be treated at the previously identified RP2D for the combination. The RP2D will be the highest dose level with ≤ 1 out of 6 patients with dose limiting toxicity and defined as the maximum tolerated dose.","label":"BAML-16-001-S10 (Closed)","type":"EXPERIMENTAL"},{"description":"The study is an open-label Phase 1b/2 clinical study of TP-0903 given in addition to decitabine in patients ≥ 60 years with newly diagnosed, previously untreated AML with TP53 mutations and/or complex karyotype. The Phase 1b portion of this study will use a standard 3 + 3 design with dose escalation based upon dose limiting toxicities. The maximum tolerated dose will be defined as the highest dose where at most 1 patient in 6 experiences dose-limiting toxicity, and this is generally the recommended Phase 2 dose (RP2D). Once the RP2D is determined from Phase 1b, patients will be enrolled at this dose level to initiate the Phase 2 portion of the study.","label":"BAML-16-001-S14 (Closed)","type":"EXPERIMENTAL"},{"description":"This is an open-label phase 2 clinical study to assess the feasibility and efficacy of a combination based approach to the treatment of IDH1 mutant AML. On day 1 of the trial, all enrolled participants will be initiated on therapy with the IDH1 inhibitor AG-120 given daily together with azacitidine (days 1-5 and 8-9 or 7 consecutive days 1-7) in 28 day cycles for IDH1 mutant patients. Those patients who have achieved a response, defined as complete response or complete response with incomplete blood count recovery, by the end of cycle 6, will continue on combination therapy for a total of 12 cycles and then patients will go onto receive monotherapy with AG-120 until disease progression or unacceptable side effects that mandate discontinuation of therapy. Patients who cannot complete 12 cycles of azacitidine may proceed onto monotherapy with AG-120.","label":"BAML-16-001-S16 (Closed)","type":"EXPERIMENTAL"},{"description":"This is an open-label Phase 1b clinical study of AZD5991 + azacitidine in patients aged ≥60 years with newly diagnosed, previously untreated, hypermethylated and marker-negative AML. The phase 1b1 study will adopt a standard 3+3 design with dose escalation based upon dose limiting toxicities. The recommended Phase 2 dose (RP2D) is defined in this study as the highest dose level where less than 2 dose limiting toxicities (DLT) are observed out of 6 patients. Once the RP2D is defined, patients will be enrolled into 2 separate cohorts (hypermethylation and marker negative group) for the phase 1b2 expansion. These 2 groups will both be treated at the RP2D determined from phase 1b1.","label":"BAML-16-001-S18 (Closed)","type":"EXPERIMENTAL"},{"description":"\\*\\*Recruiting\\*\\* Bleximenib in combination with remission induction and consolidation therapy, followed by bleximenib maintenance therapy. Treatment will continue until PD, unacceptable toxicity or other protocol defined criteria for discontinuation (whichever comes first).","label":"S25/HO181 (Arm 1): Std of care treatment plus bleximenib and also maintenance treatment w/bleximenib","type":"EXPERIMENTAL"},{"description":"\\*\\*Recruiting\\*\\* Bleximenib in combination with remission induction and consolidation therapy, followed by placebo maintenance therapy. Treatment will continue until PD, unacceptable toxicity or other protocol defined criteria for discontinuation (whichever comes first)","label":"S25/HO181 (Arm 2): Standard of care treatment plus bleximenib and maintenance treatment w/ a placebo","type":"EXPERIMENTAL"},{"description":"\\*\\*Recruiting\\*\\* Placebo comparator in combination with remission induction and consolidation therapy, followed by placebo maintenance therapy. Treatment will continue until PD, unacceptable toxicity or other protocol defined criteria for discontinuation (whichever comes first).","label":"S25/HO181 (Arm 3): Standard of care treatment plus a placebo and maintenance treatment w/ a placebo","type":"PLACEBO_COMPARATOR"},{"description":"\\*\\*Recruiting\\*\\*\n\nday 1-28 Placebo\n\nTreatment will be on a continuous 28-day cycle schedule and continued until disease progression, development of unacceptable toxicity, death, withdrawal by subject or other protocol defined criteria for discontinuation (whichever comes first).","label":"BAML-16-001-S26/HO177 (Revumenib-placebo)","type":"PLACEBO_COMPARATOR"},{"description":"\\*\\*Recruiting\\*\\*\n\nday 1-28 Revumenib\n\nTreatment will be on a continuous 28-day cycle schedule and continued until disease progression, development of unacceptable toxicity, death, withdrawal by subject or other protocol defined criteria for discontinuation (whichever comes first).","label":"BAML-16-001-S26/HO177 (Revumenib)","type":"EXPERIMENTAL"}],"collaborators":["Syndax Pharmaceuticals","Stichting Hemato-Oncologie voor Volwassenen Nederland","AVEO Pharmaceuticals, Inc."],"completion_date":{"date":"2032-12","type":"ESTIMATED"},"conditions":["Previously Untreated Relapsed Refractory Acute Myeloid Leukemia"],"enrollment":{"count":3000,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Samalizumab (BAML-16-001-S1)","otherNames":[],"type":"BIOLOGICAL"},{"name":"BI 836858 (BAML-16-001-S2)","otherNames":[],"type":"BIOLOGICAL"},{"name":"Laboratory Biomarker Analysis","otherNames":[],"type":"OTHER"},{"name":"Daunorubicin (BAML-16-001-S1)","otherNames":[],"type":"DRUG"},{"name":"Cytarabine (BAML-16-001-S1)","otherNames":[],"type":"DRUG"},{"name":"Azacitidine (BAML-16-001-S2)","otherNames":[],"type":"DRUG"},{"name":"AG-221 (BAML-16-001-S3)","otherNames":["Enasidenib"],"type":"DRUG"},{"name":"Azacitidine (BAML-16-001-S3)","otherNames":[],"type":"DRUG"},{"name":"Entospletinib (BAML-16-001-S4)","otherNames":["GS-9973, ENTO"],"type":"DRUG"},{"name":"Azacitidine (BAML-16-001-S4)","otherNames":[],"type":"DRUG"},{"name":"Entospletinib (BAML-16-001-S5)","otherNames":["GS-9973, ENTO"],"type":"DRUG"},{"name":"Decitabine (BAML-16-001-S5)","otherNames":[],"type":"DRUG"},{"name":"Entospletinib (BAML-16-001-S6)","otherNames":["GS-9973, ENTO"],"type":"DRUG"},{"name":"Daunorubicin (BAML-16-001-S6)","otherNames":[],"type":"DRUG"},{"name":"Cytarabine (BAML-16-001-S6)","otherNames":[],"type":"DRUG"},{"name":"Pevonedistat (BAML-16-001-S9)","otherNames":["TAK-924, MLN4924"],"type":"DRUG"},{"name":"Azacitidine (BAML-16-001-S9)","otherNames":[],"type":"DRUG"},{"name":"AG-120 (BAML-16-001-S16)","otherNames":[],"type":"DRUG"},{"name":"Azacitidine (BAML-16-001-S16)","otherNames":[],"type":"DRUG"},{"name":"Gilteritinib (BAML-16-001-S8 Group 1)","otherNames":[],"type":"DRUG"},{"name":"Decitabine (BAML-16-001-S8 Group 1)","otherNames":[],"type":"DRUG"},{"name":"AZD5153 (BAML-16-001-S10)","otherNames":[],"type":"DRUG"},{"name":"Venetoclax (BAML-16-001-S10)","otherNames":[],"type":"DRUG"},{"name":"TP-0903 (BAML-16-001-S14)","otherNames":[],"type":"DRUG"},{"name":"Decitabine (BAML-16-001-S14)","otherNames":[],"type":"DRUG"},{"name":"Decitabine (BAML-16-001-S8 Group 2)","otherNames":[],"type":"DRUG"},{"name":"Venetoclax (BAML-16-001-S8 Group 2)","otherNames":[],"type":"DRUG"},{"name":"AZD5991 (BAML-16-001-S18)","otherNames":[],"type":"DRUG"},{"name":"Azacitidine (BAML-16-001-S18)","otherNames":[],"type":"DRUG"},{"name":"SNDX-5613 (BAML-16-001-S17)","otherNames":[],"type":"DRUG"},{"name":"Azacitidine (BAML-16-001-S17)","otherNames":[],"type":"DRUG"},{"name":"Venetoclax (BAML-16-001-S17)","otherNames":[],"type":"DRUG"},{"name":"Gilteritinib (BAML-16-001-S8 Group 2)","otherNames":[],"type":"DRUG"},{"name":"Venetoclax (BAML-16-001-S12 Arm A)","otherNames":[],"type":"DRUG"},{"name":"Azacitidine (BAML-16-001-S12 Arm A)","otherNames":[],"type":"DRUG"},{"name":"Venetoclax (BAML-16-001-S12 Arm B)","otherNames":[],"type":"DRUG"},{"name":"Azacitidine (BAML-16-001-S12 Arm B)","otherNames":[],"type":"DRUG"},{"name":"ZE46-0134 (BAML-16-001-S21 Group 1)","otherNames":[],"type":"DRUG"},{"name":"ficlatuzumab (BAML-16-001-S24)","otherNames":[],"type":"DRUG"},{"name":"Azacitidine (BAML-16-001-S24)","otherNames":[],"type":"DRUG"},{"name":"Venetoclax (BAML-16-001-S24)","otherNames":[],"type":"DRUG"},{"name":"ZE46-0134 (BAML-16-001-S21 Group 2)","otherNames":[],"type":"DRUG"},{"name":"Bleximenib (BAML-16-001-S25/HO181)","otherNames":[],"type":"DRUG"},{"name":"Cytarabine (BAML-16-001-S25/HO181)","otherNames":[],"type":"DRUG"},{"name":"Daunorubicin or Idarubicin (BAML-16-001-S25/HO181)","otherNames":[],"type":"DRUG"},{"name":"Placebo (BAML-16-001-S25/HO181)","otherNames":[],"type":"DRUG"},{"name":"Revumenib (BAML-16-001-S26/HO177)","otherNames":[],"type":"DRUG"},{"name":"Placebo (BAML-16-001-S26/HO177)","otherNames":[],"type":"DRUG"}],"last_update":"2026-09-03","lead_sponsor":"Beat AML, LLC","official_title":"A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)","overall_status":"RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2032-12","type":"ESTIMATED"},"primary_outcomes":[{"measure":"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","timeFrame":"7 days"},{"measure":"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","timeFrame":"7 days"},{"measure":"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.","timeFrame":"Up to 5 years"},{"measure":"BAML-16-001-S25/HO181: Event-Free Survival (EFS) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy","timeFrame":"Up to 4 years and 5 months"},{"measure":"BAML-16-001-S26/HO177: Overall survival (OS) in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy.","timeFrame":"58 months after last patient inclusion"},{"measure":"BAML-16-001-S26/HO177: Rate of CR in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy","timeFrame":"58 months after the first randomized NPM1-mutated AML patient"}],"references":[{"citation":"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.","pmid":"42520193","type":"BACKGROUND"},{"citation":"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.","pmid":"39133932","type":"BACKGROUND"},{"citation":"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.","pmid":"33106665","type":"BACKGROUND"},{"citation":"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.","pmid":"37459200","type":"BACKGROUND"},{"citation":"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.","pmid":"33997942","type":"BACKGROUND"},{"citation":"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.","pmid":"37871309","type":"BACKGROUND"},{"citation":"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.","pmid":"37078412","type":"BACKGROUND"},{"citation":"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.","pmid":"36315007","type":"BACKGROUND"},{"citation":"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.","pmid":"40557912","type":"DERIVED"},{"citation":"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.","pmid":"40504618","type":"DERIVED"}],"start_date":{"date":"2016-11"},"study_type":"INTERVENTIONAL","title":"Study of Biomarker-Based Treatment of Acute Myeloid Leukemia","url":"https://clinicaltrials.gov/study/NCT03013998"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03013998"}