Beat AML Core Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02927106 |
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Recruitment Status :
Recruiting
First Posted : October 6, 2016
Last Update Posted : July 28, 2017
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Sponsor:
University of Florida
Collaborators:
Oregon Health and Science University
Cellworks Group Inc.
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
University of Florida
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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 |
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 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
Genetics Home Reference related topics:
Core binding factor acute myeloid leukemia
Cytogenetically normal acute myeloid leukemia
Familial acute myeloid leukemia with mutated CEBPA
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
Primary Outcome Measures :
- 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.
- 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
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: Barry C. Sawicki | (352) 273-9148 | bswcki@ufl.edu | |
| Contact: Caitlin D. Tucker, RN | (352) 372-6841 | tuckca@ufl.edu |
Locations
| United States, Florida | |
| UF Health Cancer Center | Recruiting |
| Gainesville, Florida, United States, 32608 | |
| Contact: Barry Sawicki 352-273-9148 bswcki@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 |
| 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: | July 28, 2017 |
| Last Verified: | July 2017 |
| 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:
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leukemia myeloid genomics |
Additional relevant MeSH terms:
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Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms |