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Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

StatusRecruiting
PhasePhase 2/3
Started2016-11
View on ClinicalTrials.gov ↗
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 \[e.g. myelodysplastic syndrome (MDS) or other diseases\], will be allowed to enroll to Master protocol if there is an available sub-study.

Amendment history 7 changes detected by DataLookout

2026-09-04
Phase changed: Phase 1/2 → Phase 2/3
2026-09-04
Primary endpoint(s) modified
WasClinical response rate (rate of complete and partial responses) according to International Working Group criteria for treatment outcomes in therapeutic trials in acute myeloid leukemia, 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, Proportion of patients for whom molecular, immunophenotypic, and/or biochemical studies are completed in < 7 calendar days for assignment of treatment
NowBAML-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-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: Proportion of patients for whom molecular, immunophenotypic, and/or biochemical studies are completed in < 7 calendar days for assignment of treatment, 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
2026-09-04
Trial arms changed: 18 → 23
2026-09-04
Trial sites expanded: 19 → 31 locations
2026-09-04
Primary completion pushed: 2028-12 → 2032-12
2026-09-04
Completion pushed: 2028-12 → 2032-12
2026-09-04
Interventions modified
Trial Details
NCT Number NCT03013998
Lead Sponsor Beat AML, LLC
Collaborators: Syndax Pharmaceuticals, Stichting Hemato-Oncologie voor Volwassenen Nederland, AVEO Pharmaceuticals, Inc.
Conditions Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
Enrollment 3,000 participants
Start Date 2016-11
Primary Completion 2032-12 (estimated)
Study Completion 2032-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-03