Clinical trial NCT02927106: Beat AML Core Study
Official title: Beat AML: Personalized Medicine for Acute Myeloid Leukemia Based on Functional Genomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Keywords: leukemia
myeloid
genomics
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: Cellworks Group Inc.
name: The Leukemia and Lymphoma Society
First posted: 2016-10-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 50 subjects with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) will be enrolled in this study.

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.

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

Primary outcomes:
measure: the genomic abnormality spectrum
timeFrame: 5 years
measure: drug sensitivity
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Cancer Center
state: Florida
Study officials:
affiliation: University of Florida
name: Christopher R. Cogle, MD
role: PRINCIPAL_INVESTIGATOR
References: