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IDH1/IDH2 Mutation Frequency in Acute Myeloblastic Patients

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ClinicalTrials.gov Identifier: NCT03204838
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
ADOLFO MARTINEZ TOVAR, Hospital General de México Dr. Eduardo Liceaga

Brief Summary:

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.


Condition or disease Intervention/treatment
Acute Myeloid Leukemia (AML) Genetic: IDH mutation test performed at diagnosis

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: STUDY TITLE IDH1/IDH2 Mutation Frequency in Acute Myeloblastic Patients and Myelodysplasticsyndromes, Clinical Response to Treatment
Estimated Study Start Date : July 10, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 5, 2020


Group/Cohort Intervention/treatment
AML patients
Adult AML patients with the IDH mutation test performed at diagnosis.
Genetic: IDH mutation test performed at diagnosis
Observation of the test result




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Retrospective phase clinical and molecular data of patients without treatment with morphological, genetic, immunophenotype classification. Molecular biology (AML-ETO, PMR-RAR alpha, Inv 16, FLT 3, CEBP mutation 50 cases , 100 controls. Address Hospital General de Mexico , Hematology service ( external consult and transfusional area). (Lysis Buffer)


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
AML patients without treatment with morphological, genetic, immunophenotype classification.
Criteria

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


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): NCT03204838


Contacts
Contact: Juan J Collazo Jaloma, phD 5527892000 ext 1609 mtadolfo73@hgm.mx
Contact: Christian C Ramos Peñafiel, phD 5527892000 ext 1609 leukemiachop@hotmail.com

Locations
Mexico
Ciudad de Mexico Recruiting
Mexico City, Mexico, 06720
Contact: ADOLFO MARTINEZ TOVAR, phD    5527892000 ext 1609    mtadolfo73@hotmail.com   
Contact: ADOLFO SERVICION DE BIOLOGIA MOLECULAR, phD    5527892000 ext 1609    mtadolfo73@hotmail.com   
Sponsors and Collaborators
Hospital General de Mexico
Investigators
Principal Investigator: ADOLFO A Martinez Tovar, phD Hospital General de Mexico

Publications of Results:
Other Publications:
Responsible Party: ADOLFO MARTINEZ TOVAR, Principal Investigator, Hospital General de México Dr. Eduardo Liceaga
ClinicalTrials.gov Identifier: NCT03204838     History of Changes
Other Study ID Numbers: Hospital General de Mexico
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by ADOLFO MARTINEZ TOVAR, Hospital General de México Dr. Eduardo Liceaga:
IDH1, IDH2, MUTATION, AML

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