Official Title
Beat AML: Personalized Medicine for Acute Myeloid Leukemia Based on Functional Genomics
Brief Title
Beat AML Core Study
Protocol ID
NCT02927106
Lead Sponsor
University of Florida
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).
Detailed Description
As part of normal clinical care, patients will undergo a peripheral blood draw and bone
marrow aspiration & biopsy. Blood draws and bone marrow aspirations are performed at the
time of diagnosis, after treatments , disease progression, and relapse. Under normal
clinical care, patient specimens are analyzed by cytogenetics (giemsa staining),
fluorescence in situ hybridization (FISH), and gene mutation profiling. Clinically,
treatment can begin before these molecular diagnostics are available.
As part of this repository study, subjects are asked to:
- Allow access to banked blood and bone marrow specimens in IRB approved protocol #
532-2012.
- Donate peripheral blood specimens whenever blood is already being drawn for clinical
purposes such as at times of diagnosis, relapse, refractory disease or disease
progression. Additional samples may be requested at other standard of care visits in
the event that initial samples are not viable for DNA sequencing, phenotyping, or
functional assays for patients with AML, if disease is present.
- Donate bone marrow aspirate specimens whenever bone marrow aspiration is already
being done for clinical purposes such as at times of diagnosis, relapse, refractory
disease or disease progression. If bone marrow aspirate is being collected for
banking protocol #532-2012, then an aliquot of the banked specimen will be accessed
rather than collect an additional bone marrow aspirate for this study.
- Undergo skin biopsy and donate the skin biopsy specimen for genomic profiling.
- Allow bone marrow, peripheral blood and skin biopsy specimens to be collected for
genomic profiling and ex vivo drug sensitivity testing.
Study Period
-
Enrollment Count
22 participants
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 17 years of age or less
- greater than 80 years of age
Filters
Acute Myeloid Leukemia
COMPLETED
ADULT
OLDER_ADULT