Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

About the trial

Sponsor

Beat AML, LLC (with Syndax Pharmaceuticals, Stichting Hemato-Oncologie voor Volwassenen Nederland, AVEO Pharmaceuticals, Inc.)

Tested

Samalizumab (BAML-16-001-S1) (biological), BI 836858 (BAML-16-001-S2) (biological), Laboratory Biomarker Analysis (other), Daunorubicin (BAML-16-001-S1) (drug), Cytarabine (BAML-16-001-S1) (drug), Azacitidine (BAML-16-001-S2) (drug), AG-221 (BAML-16-001-S3) (drug), Azacitidine (BAML-16-001-S3) (drug), Entospletinib (BAML-16-001-S4) (drug), Azacitidine (BAML-16-001-S4) (drug), Entospletinib (BAML-16-001-S5) (drug), Decitabine (BAML-16-001-S5) (drug), Entospletinib (BAML-16-001-S6) (drug), Daunorubicin (BAML-16-001-S6) (drug), Cytarabine (BAML-16-001-S6) (drug), Pevonedistat (BAML-16-001-S9) (drug), Azacitidine (BAML-16-001-S9) (drug), AG-120 (BAML-16-001-S16) (drug), Azacitidine (BAML-16-001-S16) (drug), Gilteritinib (BAML-16-001-S8 Group 1) (drug), Decitabine (BAML-16-001-S8 Group 1) (drug), AZD5153 (BAML-16-001-S10) (drug), Venetoclax (BAML-16-001-S10) (drug), TP-0903 (BAML-16-001-S14) (drug), Decitabine (BAML-16-001-S14) (drug), Decitabine (BAML-16-001-S8 Group 2) (drug), Venetoclax (BAML-16-001-S8 Group 2) (drug), AZD5991 (BAML-16-001-S18) (drug), Azacitidine (BAML-16-001-S18) (drug), SNDX-5613 (BAML-16-001-S17) (drug), Azacitidine (BAML-16-001-S17) (drug), Venetoclax (BAML-16-001-S17) (drug), Gilteritinib (BAML-16-001-S8 Group 2) (drug), Venetoclax (BAML-16-001-S12 Arm A) (drug), Azacitidine (BAML-16-001-S12 Arm A) (drug), Venetoclax (BAML-16-001-S12 Arm B) (drug), Azacitidine (BAML-16-001-S12 Arm B) (drug), ZE46-0134 (BAML-16-001-S21 Group 1) (drug), ficlatuzumab (BAML-16-001-S24) (drug), Azacitidine (BAML-16-001-S24) (drug), Venetoclax (BAML-16-001-S24) (drug), ZE46-0134 (BAML-16-001-S21 Group 2) (drug), Bleximenib (BAML-16-001-S25/HO181) (drug), Cytarabine (BAML-16-001-S25/HO181) (drug), Daunorubicin or Idarubicin (BAML-16-001-S25/HO181) (drug), Placebo (BAML-16-001-S25/HO181) (drug), Revumenib (BAML-16-001-S26/HO177) (drug), Placebo (BAML-16-001-S26/HO177) (drug)

Dates

Started 2016-11; completion 2032-12

Results posted

Not yet

This screening and multi-sub-study Phase 1b/2/3 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes marker negative sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies. Patients with myeloid malignancies \[e.g. myelodysplastic syndrome (MDS) or other di…

From ClinicalTrials.gov, last updated 2026-09-03. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sumitomo Pharma America, Inc. reported $26,963 in research payments for this study in 2025 (1 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.