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Biomarker-Based Treatment for Acute Myeloid Leukemia

This study is looking for adults with acute myeloid leukemia (AML) that has come back or not responded to previous treatment. It aims to find a faster way to identify specific genetic markers in your AML to match you with the most suitable treatment. You could receive investigational treatments like Samalizumab or BI 836858, or standard chemotherapy drugs like Daunorubicin and Cytarabine, depending on your AML's unique characteristics. The researchers want to see how quickly they can assign you to a targeted treatment and how well these treatments work, including how many patients have a complete or partial response. The study plans to enroll 3000 participants.

Study design
This is a multi-sub-study Phase 1b/2 trial that uses genomic screening to assign participants to different treatment groups within a "Master Protocol." It is an interventional study.
What's involved
You would receive intravenous (IV) infusions of study drugs over cycles lasting 21 or 28 days, potentially for up to 2 years. You would also undergo molecular genomic assessments.
Compensation
Not stated in the trial record.
Follow-up
Clinical response will be measured for up to 5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03013998

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Recruiting
PHASE1Ages 18+InterventionalTreatment
Beat AML, LLC
~3,000 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Samalizumab (BAML-16-001-S1)BI 836858 (BAML-16-001-S2)Laboratory Biomarker AnalysisDaunorubicin (BAML-16-001-S1)Cytarabine (BAML-16-001-S1)Azacitidine (BAML-16-001-S2)

At a glance

Recruiting sites
12 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients for whom molecular, immunophenotypic, and/or biochemical studies are completed in < 7 calendar days for assignment of treatment
Measured over 7 days
+2 more outcomes measured

Conditions

Previously Untreated Relapsed Refractory Acute Myeloid Leukemia

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Where it's being run

19 sites across 16 states
California2
Florida2
Ohio2
Arizona1
Colorado1
Georgia1
Illinois1
Kansas1

Study leadership

  • John C Byrd, MD · PRINCIPAL_INVESTIGATOR · Beat AML

Who to contact

Ashley Yocum, PhD
[email protected]
301-814-2788
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults, age 60 years or older at the time of diagnosis unless in a specific known cytogenetic and genomic group for which treatment in Group A, B, or C is allowed by the sub-study where age 18 and older is allowed. In such case, waiting for Foundation Medicine test results would not be required to proceed with sub-study treatment. Patients \< 60 years old who are screened but do not fall within the cytogenetic and genomic open sub-studies would still be followed on the M1 Master Protocol and not considered screen fails.
Patients must be able to understand and provide written informed consent

Exclusion

Acute promyelocytic leukemia
Clinically active central nervous system (CNS) involvement by AML. A patient may be considered eligible if CNS leukemia is showing response to treatment at study entry and should continue to receive intrathecal therapy as clinical indicated. Patients who require or are undergoing craniospinal irradiation of disease control would not be eligible for participation.
Signs of leukostasis requiring urgent therapy
Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis
Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol (including failure to collect genomics samples for screening), or potentially hamper compliance with study treatment and follow-up
Any other significant medical condition, including psychiatric illness or laboratory abnormality, that would preclude the patient participating in the trial or would confound the interpretation of the results of the trial.

What this trial measures

  • Proportion of patients for whom molecular, immunophenotypic, and/or biochemical studies are completed in < 7 calendar days for assignment of treatment7 days

    The feasibility of completing molecular, genetic, immunophenotypic, and biochemical testing for assignment of therapy will be assessed based on the proportion of patients for whom testing is completed within 7 days of the registration sample arriving at the laboratory

  • 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 studies7 days

    The feasibility of assigning patients to a treatment group will be assessed based on the proportion who are eligible for screening in this study who are assigned to treatment either on this study or an industry study relevant to the specific marker group and not unassignable due to insufficient material, laboratory error, or any other factors

  • Clinical response rate (rate of complete and partial responses) according to International Working Group criteria for treatment outcomes in therapeutic trials in acute myeloid leukemiaUp to 5 years