IDH1/IDH2 Mutation Frequency in Acute Myeloblastic Patients
STUDY TITLE IDH1/IDH2 Mutation Frequency in Acute Myeloblastic Patients and Myelodysplasticsyndromes, Clinical Response to Treatment
This leukemia is characterized by a poor prognosis for most patients, as they have a high relapse rate despite aggressive treatment with chemotherapy agents and allogeneic bone marrow transplantation. It has been proposed that relapse can be attributed to a leukemic cells population with quiescence properties that are resistant to chemotherapy, known as leukemic stem cells (LSCs). Clinical trials shown a major LSCs percentage than diagnosis correlated with worst prognosis or minimal residual disease with AML.
AML is most common in adults and represents about 40% of all leukemia types in American Continent. In Mexican patients with AML age median is 32 years, lower than other international series. Genomic and functional studies have identified two classes of mutations, which cooperate during AML development.
Somatic mutations have been identified recently that codify for isocitrate dehydrogenase (IDH). These genes codify key metabolic enzymes, which convert isocitrate into α-ketoglutarate (α-KG).15-16From which IDH1 and IDH2 genes presenta high frequency of mutations in AML and other types of tumors. IDH mutations affect mainly active site residues (for example, IDH1 R132, IDH2 R140 or IDH2 R172), resulting in the normal enzymatic function loss abnormally converting α-KG to 2-hydroxiglutarate (2-HG).
"Oncometabolyte" 2-HG may competitively inhibit multiple α-KG depending dioxygenases, including key epigenetic regulators as histones demethylases and TET proteins. Consequently, IDH mutations are associated with chromatin alterations including global alteration of histones and NDA methylation. This is the reason of the need to identify such mutations of genes (IDH1/IDH2) in patients with SMD and AML entering Hematology service of the Hospital General de Mexico from 2017 to 2019, and determine clinical impact in prognosis and monitoring the response to therapy, as well as prognosis and survival.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Acute myeloid leukemia (AML) is a heterogeneous cancer implying accumulation of mature cells. This leukemia is characterized by a poor prognosis for most patients, as they have a high relapse rate despite aggressive treatment with chemotherapy agents and allogeneic bone marrow transplantation. It has been proposed that relapse can be attributed to a leukemic cells population with quiescence properties that are resistant to chemotherapy, known as leukemic stem cells (LSCs). Clinical trials shown a major LSCs percentage than diagnosis correlated with worst prognosis or minimal residual disease with AML.
AML is most common in adults and represents about 40% of all leukemia types in American Continent. In Mexican patients with AML age median is 32 years, lower than other international series.
AML may be classified in 8 sub-types based on FAB Classification (French-American-British Classification). FAB Classification is based on morphology and cytogenetic. Sub-types are M0 to M7, based on the type of leukemia cells and their maturity. Other classification system used is the one of the World Health Organization (WHO) that classifies the types of leukemia based on genetic/molecular alteration or existence of other potential factors impacting clinical prognosis. The Hospital General de Mexico classifies the leukemia types based on morphologic, immunophenotype, genetic and sometimes in molecular criteria.
Genomic and functional studies have identified two classes of mutations, which cooperate during AML development. Class I mutations, which confer proliferative and survival advantage to hematopoietic stem cells, an example is the occurrence of mutations in NRAS or KRAS genes, or mutations affecting receptor tyrosine kinase FLT3.Class II mutations characterize for promoting self-renewal and blocking differentiation of hematopoietic stem cells. These mutations include certain translocation, an example of this type of mutations is gene MLL1 derived from t(8;21) (AML1-ETO).Major mutations in AML are commonly detected in cytogenetically Normal (CN) cases representing 40% to 50% of all AML.
Such aberrations have demonstrated impacting prognosis of patients with AML. These genes include: FLT3, NPM1, CEBPA, MLL, NRAS, KIT, WT1, RUNX1, TET2, IDH1/2, DNMT3A, ASXL1, PHF6. For example, mutations in FLT3 (37%-46% of patients) indicate poor prognosis. On the contrary, mutations in NPM1 (48%-53% of patients) and CEBPA (13% to 15% of patients) indicate a better prognosis. AMLis a neoplastic clonal disease that originates from progressive accumulation of genetic and epigenetic aberrations affecting mechanisms regulating proliferation and differentiation of hematopoietic trunk cells (HTC). However, impact of these mutations in survival and chemo resistance to new therapeutic agents in LSCs, including emergent therapies against LSCs, which have not been described. In the Hospital General de Mexico, the prognosis of LAM at 5 years is only 30%. For this, it is necessary to detect mutation pattern of genes that may contribute to AML development or prognosis in Mexican patients of the Hospital General de México.
Somatic mutations have been identified recently that codify for isocitrate dehydrogenase (IDH). These genes codify key metabolic enzymes, which convert isocitrate into α-ketoglutarate (α-KG).15-16From which IDH1 and IDH2 genes presenta high frequency of mutations in AML and other types of tumors. IDH mutations affect mainly active site residues (for example, IDH1 R132, IDH2 R140 or IDH2 R172), resulting in the normal enzymatic function loss abnormally converting α-KG to 2-hydroxiglutarate (2-HG).
"Oncometabolyte" 2-HG may competitively inhibit multiple α-KG depending dioxygenases, including key epigenetic regulators as histones demethylases and TET proteins. Consequently, IDH mutations are associated with chromatin alterations including global alteration of histones and NDA methylation. This is the reason of the need to identify such mutations of genes (IDH1/IDH2) in patients with SMD and AML entering Hematology service of the Hospital General de Mexico from 2017 to 2019, and determine clinical impact in prognosis and monitoring the response to therapy, as well as prognosis and survival..
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Juan J Collazo Jaloma, phD
- Phone Number: 1609 5527892000
- Email: mtadolfo73@hgm.mx
Study Contact Backup
- Name: Christian C Ramos Peñafiel, phD
- Phone Number: 1609 5527892000
- Email: leukemiachop@hotmail.com
Study Locations
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-
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Mexico City, Mexico, 06720
- Recruiting
- Ciudad de Mexico
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Contact:
- ADOLFO MARTINEZ TOVAR, phD
- Phone Number: 1609 5527892000
- Email: mtadolfo73@hotmail.com
-
Contact:
- ADOLFO SERVICION DE BIOLOGIA MOLECULAR, phD
- Phone Number: 1609 5527892000
- Email: mtadolfo73@hotmail.com
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Signed written informed consent according to ICH/GCP and national local laws
AML patients; >18 years IDH mutation test perfomed at diagnosis
Exclusion Criteria:
Patients whom don't continue treatment. AML-M3 subtype according to the FAB
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Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
AML patients
Adult AML patients with the IDH mutation test performed at diagnosis.
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Observation of the test result
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identify the mutation frequency of IDH1/IDH2 genes in patients with AML entering Hematology service of the HGM and clinical impact in treatment respons
Time Frame: At two years from study entry
|
Number of patients with the IDH mutation in AML at initial diagnosis
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At two years from study entry
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: ADOLFO A Martinez Tovar, phD, Hospital General de Mexico
Publications and helpful links
General Publications
- Gutierrez-Malacatt H, Ayala-Sanchez M, Aquino-Ortega X, Dominguez-Rodriguez J, Martinez-Tovar A, Olarte-Carrillo I, Martinez-Hernandez A, C CC, Orozco L, Cordova EJ. The rs61764370 Functional Variant in the KRAS Oncogene is Associated with Chronic Myeloid Leukemia Risk in Women. Asian Pac J Cancer Prev. 2016;17(4):2265-70. doi: 10.7314/apjcp.2016.17.4.2265.
- Alonso-Rangel L, Benitez-Guerrero T, Martinez-Vieyra I, Cisneros B, Martinez-Tovar A, Winder SJ, Cerecedo D. A role for dystroglycan in the pathophysiology of acute leukemic cells. Life Sci. 2017 Aug 1;182:1-9. doi: 10.1016/j.lfs.2017.06.004. Epub 2017 Jun 4.
- Santoyo-Sanchez A, Ramos-Penafiel CO, Saavedra-Gonzalez A, Gonzalez-Almanza L, Martinez-Tovar A, Olarte-Carrillo I, Collazo-Jaloma J. [The age and sex frequencies of patients with leukemia seen in two reference centers in the metropolitan area of Mexico City]. Gac Med Mex. 2017 Jan-Feb;153(1):44-48. Spanish.
- Olarte Carrillo I, Ramos Penafiel C, Miranda Peralta E, Rozen Fuller E, Kassack Ipina JJ, Centeno Cruz F, Garrido Guerrero E, Collazo Jaloma J, Nacho Vargas K, Martinez Tovar A. Clinical significance of the ABCB1 and ABCG2 gene expression levels in acute lymphoblastic leukemia. Hematology. 2017 Jun;22(5):286-291. doi: 10.1080/10245332.2016.1265780. Epub 2016 Dec 14.
Study record dates
Study Major Dates
Study Start (Anticipated)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Hospital General de Mexico
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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