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Beat AML Core Study

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ClinicalTrials.gov Identifier: NCT02927106
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
Oregon Health and Science University
Cellworks Group Inc.
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
University of Florida

Study Description
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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).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Genetic: Genomics Diagnostic Test: Drug Sensitivity Assay Genetic: Proteomics Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Beat AML: Personalized Medicine for Acute Myeloid Leukemia Based on Functional Genomics
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : February 15, 2024
Estimated Study Completion Date : February 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Genetic: Genomics
AML cells will be examined by Next Generation Sequencing using an Illumina DNA sequencer.
Other Name: Computational Biology

Diagnostic Test: Drug Sensitivity Assay
Ex vivo drug sensitivity testing will be performed on AML cells.

Genetic: Proteomics
Biomarkers and genomic signatures will be identified in AML cells that correlate with disease response and adverse events.


Outcome Measures
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Primary Outcome Measures :
  1. the genomic abnormality spectrum [ Time Frame: 5 years ]
    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.

  2. drug sensitivity [ Time Frame: 5 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927106


Contacts
Contact: Christina Cline, RN (352) 273-6840 clcline@ufl.edu

Locations
United States, Florida
UF Health Cancer Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Christina Cline, RN    352-273-6840    clcline@ufl.edu   
Sponsors and Collaborators
University of Florida
Oregon Health and Science University
Cellworks Group Inc.
The Leukemia and Lymphoma Society
Investigators
Principal Investigator: Christopher R. Cogle, MD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02927106     History of Changes
Other Study ID Numbers: IRB201601364
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
leukemia
myeloid
genomics

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms