Actively Recruiting
Feasibility Study of Individualized Treatment Recommendations for Acute Myeloid Leukemia Based on High Throughput Screening and Genomics Data
Led by City of Hope Medical Center · Updated on 2026-05-29
18
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with relapsed or refractory acute myeloid leukemia (AML) who have fewer approved treatment options available. Researchers are evaluating whether combining high throughput drug screening (HTS) with detailed molecular testing called HopeSeq can help doctors identify the most effective treatments for each patient. This study aims to personalize therapy by testing how a patient’s own AML cells respond to various drugs and drug combinations, using advanced genetic and functional analysis methods. Participants provide extra blood or bone marrow samples during routine procedures. These samples undergo HTS at the University of Washington and molecular analysis with HopeSeq, which sequences hundreds of relevant genes. A specialized Functional Molecular Tumor Board reviews these results along with clinical information to recommend individualized treatment options. The patient’s doctor then discusses these recommendations with the patient to decide the best plan, which must be approved by insurance. No treatments are administered as part of the study. Participants will be followed retrospectively through medical record reviews at 6 and 12 months to assess how well the testing predicted treatment responses and survival outcomes. The study tracks the speed of test results, success rates of testing, treatment initiation, remission, and overall survival. The total participation involves sample collection at enrollment and follow-up reviews over one year to understand the usefulness of these personalized testing methods in real-world care.
CONDITIONS
Brief Title
Individualized AML Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented informed consent of the participant and/or legally authorized representative
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- Age 18 years or older
- ECOG performance status 3 or less
- Histologically confirmed AML according to ICC or WHO criteria
- Relapsed or refractory to prior treatment: one or more regimens if adverse risk, two or more if favorable/intermediate risk
- Sufficient bone marrow or peripheral blood sample for testing, or biopsy/fluids if marrow not available
- Expected survival longer than 100 days
- Fully recovered from acute toxic effects (except hair loss) to Grade 1 or less from prior anti-cancer therapy
You will not qualify if you...
- Treatment with chemotherapy to control AML allowed between day -18 and -1
- No live vaccines planned or received during the study
- Presence of t(15;17) abnormality or acute promyelocytic leukemia (FAB class M3-AML)
- Active central nervous system disease unless treated and responding
- Active graft versus host disease
- Unstable cardiac disease such as recent heart attack within 6 months or uncontrolled atrial fibrillation/hypertension
- Clinically significant uncontrolled illness or active infection
- Pregnant or breastfeeding females
- Any condition or active cancer that contraindicates participation due to safety concerns
- Inability to comply with study procedures as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 days from sample acquisition
Participants provide bone marrow aspirate, peripheral blood, or tissue samples for high throughput drug screening and genomic analyses to inform treatment recommendations.
Samples collected at 1 visit (in-person)
Duration - Up to 1 year
Participants are observed for treatment initiation, response to treatment, and overall survival over the course of up to 1 year.
Follow-up visits as part of routine care
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
Research Team
P
Pamela Becker, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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