Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Description

This screening and multi-sub-study Phase 1b/2 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 a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

Conditions

Previously Untreated Relapsed Refractory Acute Myeloid Leukemia

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Study Overview

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Study Details

Study overview

This screening and multi-sub-study Phase 1b/2 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 a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Condition
Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic Arizona, Phoenix, Arizona, United States, 85054

Los Angeles

UCLA Ronald Reagan Medical Center, Los Angeles, California, United States, 90095

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Denver

University of Colorado, Denver, Colorado, United States, 80203

Gainesville

University of Florida Health Shands Cancer Hospital, Gainesville, Florida, United States, 32608

Jacksonville

Mayo Clinic Florida, Jacksonville, Florida, United States, 32224

Atlanta

Emory University, Atlanta, Georgia, United States, 30308

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Fairway

University of Kansas Clinical Research Center, Fairway, Kansas, United States, 66205

Baltimore

University of Maryland Medical Center, Baltimore, Maryland, United States, 21201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 or B is allowed by the sub-study where age 18 and older is allowed. 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 Master Protocol and not considered screen fails.
  • * Subjects must be able to understand and provide written informed consent
  • * Cohort Inclusion Criteria - Group A: Subjects must have previously untreated acute myeloid leukemia (AML) according to the WHO classification with no prior treatment other than hydroxyurea. Subjects with blasts % in bone marrow of 10% to 19% or blasts in blood of 10% to 19% will be allowed to enroll to this group. For previously untreated subjects with ≥ 20% blasts in bone marrow or blood only: Prior therapy for myelodysplastic syndrome (MDS), myeloproliferative syndromes (MPD), or aplastic anemia is permitted but not with hypomethylating agents.
  • * Cohort Inclusion Criteria - Group B: Subjects must have relapsed or refractory AML according to the WHO classification. For study purposes, refractory AML is defined as failure to ever achieve CR or recurrence of AML within 6 months of achieving CR; relapsed AML is defined as all others with disease after prior remission. For select genomic aberrations specified in the studies, patients ≥ 18 years of age may be allowed to enroll in this portion of the study.
  • * Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML or involved with 10% to 19% blasts to enter the study)
  • * Acute promyelocytic leukemia
  • * Symptomatic central nervous system (CNS) involvement by AML
  • * 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, 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Beat AML, LLC,

John C Byrd, MD, PRINCIPAL_INVESTIGATOR, Beat AML

Study Record Dates

2026-12