Beat AML Core Study



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 80
Updated:1/27/2019
Start Date:February 15, 2017
End Date:February 15, 2025
Contact:Christina Cline, RN
Email:clcline@ufl.edu
Phone:(352) 273-6840

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Beat AML: Personalized Medicine for Acute Myeloid Leukemia Based on Functional Genomics

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).

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.

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
We found this trial at
1
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Gainesville, Florida 32610
Phone: 352-273-6840
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