Actively Recruiting
Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
Led by Beat AML, LLC · Updated on 2025-12-17
3000
Participants Needed
19
Research Sites
630 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 60 years or older at diagnosis, or 18 years and older for select genomic sub-studies
- Ability to understand and provide written informed consent
- Previously untreated AML with no prior treatment other than hydroxyurea or ATRA for suspected APL ruled out
- Patients with relapsed or refractory AML, or related myeloid malignancies, may be included in specific groups
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (for specific sub-studies)
- Adequate liver and kidney function as defined by local laboratory values
- Females must be non-childbearing, postmenopausal, or surgically sterile; males must follow criteria regarding females of childbearing potential
- Life expectancy greater than 2 years if co-morbid illness or malignancy is present
- Enrollment possible without waiting for genomic testing results for select sub-studies
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Active central nervous system involvement by AML unless responding to treatment and continuing intrathecal therapy
- Signs of leukostasis requiring urgent therapy
- Disseminated intravascular coagulopathy with active bleeding or thrombosis
- Psychological, familial, social, or geographic factors preventing informed consent or compliance
- Significant medical conditions or laboratory abnormalities that interfere with participation or result interpretation
- Active infections not under control
- Recent use of investigational agents within 1 to 4 weeks depending on half-life
- Pregnancy or lactation
- Patients with QTc prolongation beyond specified limits or certain cardiac conditions unless cleared by cardiology
- Patients requiring concomitant treatment with strong CYP3A inducers or P-glycoprotein modulators except essential medications
- Patients able and willing to receive intensive induction chemotherapy (for certain sub-studies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Completed
2
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
University of Colorado
Denver, Colorado, United States, 80203
Completed
5
University of Florida Health Shands Cancer Hospital
Gainesville, Florida, United States, 32608
Completed
6
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Completed
7
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
8
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
9
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
10
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
11
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Completed
12
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
13
UNC Hospitals, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
14
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
15
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
16
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
17
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
18
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
19
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Completed
Research Team
A
Ashley Yocum, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
18
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