Beat AML Core Study
Beat AML: Personalized Medicine for Acute Myeloid Leukemia Based on Functional Genomics
2 other identifiers
observational
22
1 country
1
Brief Summary
In this study, DNA sequencing, computational biology modeling, and ex vivo drug sensitivity assays will be utilized to define clinically relevant gene mutations and identify potential therapeutics for patients with acute myeloid leukemia (AML).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2016
CompletedFirst Posted
Study publicly available on registry
October 6, 2016
CompletedStudy Start
First participant enrolled
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2020
CompletedAugust 5, 2020
August 1, 2020
3.5 years
October 5, 2016
August 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
the genomic abnormality spectrum
AML cells in the peripheral blood and bone marrow samples will be examined by next generation sequencing using an Illumina DNA sequencer. DNA from the skin biopsy will be used as the constitutional reference DNA. Using skin DNA greatly improves the ability to accurately and precisely identify somatic mutations in the AML cells.
5 years
drug sensitivity
Ex vivo drug sensitivity testing will be performed on each subject's AML cells derived from peripheral blood and bone marrow. AML cell viability will be recorded for each treatment condition after 72 hours of treatment. A rank-ordered list of drugs will be created in order of drug toxicity.
5 years
Study Arms (1)
Acute Myeloid Leukemia (AML)
AML samples will be collected from individuals with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) as defined by World Health Organization 2016.
Eligibility Criteria
A total of 50 subjects with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) will be enrolled in this study.
You may qualify if:
- Individuals with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) as defined by World Health Organization 2016.
- ≥ 18 years of age
- Capable of providing informed consent
You may not qualify if:
- years of age or less
- greater than 80 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Oregon Health and Science Universitycollaborator
- Cellworks Group Inc.collaborator
- The Leukemia and Lymphoma Societycollaborator
Study Sites (1)
UF Health Cancer Center
Gainesville, Florida, 32608, United States
Biospecimen
Perform molecular and cellular studies on blood, skin biopsy, and bone marrow samples done at the time of diagnosis, after treatments, disease progression, and relapse.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher R. Cogle, MD
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2016
First Posted
October 6, 2016
Study Start
February 15, 2017
Primary Completion
July 29, 2020
Study Completion
July 29, 2020
Last Updated
August 5, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share