Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicentric Study.

• Sponsor: Mexican Agrupation for Hematology Study (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04311060
• Collaborator: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other), Instituto Nacional de Cancerologia de Mexico (Other), Centro Medico Nacional Siglo XXI IMSS (Other), Hospital General de México Dr. Eduardo Liceaga (Other), Hospital Regional de Alta Especialidad del Bajio (Other), Instituto Mexicano del Seguro Social (Other), Hospital Universitario Dr. Jose E. Gonzalez (Other), Hospital Regional de Alta Especialidad de Ciudad Victoria Bicentenario 2010 (Other), Hospital Juarez de Mexico (Other), Hospital Regional de Alta especialidad de Ixtapaluca (Other)
• Enrollment: 100
• Locations: 10
• Anticipated Duration (Months): 67.3
• Patients Per Site: 10
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Newly diagnosed adults patients with Acute Myeloid Leukemia will be assessed as traditionally by the treating institution using classic clinical, demographic and cytogenetic variables. Complementary molecular tests will be performed in the patients included in the study using PCR to detect classic CBF (Core Binding Factor) rearrangements: CBFB-MYH11 [inv(16)(p13;q22), isoforms A, E and D; AML-ETO (RUNX1-RUNX1T1) (t8;21)(q22;q22). NGS (Next Generation Sequencing) to detect mutations in: FLT3-ITD and TKD, NPM1, CEBPA, RUNX1, TP53, ASXL1, IDH1, IDH2 and KIT

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Diagnostic Test: Molecular panel

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicenter Study
• Anticipated Study Start Date: Mar 22, 2020
• Anticipated Primary Completion Date: Sep 30, 2025
• Anticipated Study Completion Date: Oct 31, 2025

Outcome Measures

Primary Outcome Measures

1. overall survival [3 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Newly diagnosed AML

• Over 15 years of age

• Flow cytometry confirmation

• Candidate for treatment (intensive or not intensive)

Exclusion Criteria:

• Acute Promyelocytic Leukemia

• Mixed phenotype leukemias

• Isolated myeloid sarcoma

• Blastic plasmacytoid dendritic cell neoplasm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Regional de Alta Especialidad Ixtapaluca	Ixtapaluca	Edo Mex	Mexico
2	Hospital Regional de Alta Especialidad Bajío	León	Guanajuato	Mexico
3	Hospital Universitario	Monterrey	Nuevo León	Mexico
4	Imss Umae 25	Monterrey	Nuevo León	Mexico
5	Hospital Regional de Alta Especialidad Ciudad Victoria	Ciudad Victoria	Tamaulipas	Mexico
6	Centro Médico Naciona Siglo XXI IMSS	Mexico City		Mexico
7	Hospital General de México	Mexico City		Mexico
8	Hospital Juarez de México	Mexico City		Mexico
9	Instituto Nacional de Cancerlogía	Mexico City		Mexico
10	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico Distrito Federal		Mexico	1400

Sponsors and Collaborators

• Mexican Agrupation for Hematology Study
• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Instituto Nacional de Cancerologia de Mexico
• Centro Medico Nacional Siglo XXI IMSS
• Hospital General de México Dr. Eduardo Liceaga
• Hospital Regional de Alta Especialidad del Bajio
• Instituto Mexicano del Seguro Social
• Hospital Universitario Dr. Jose E. Gonzalez
• Hospital Regional de Alta Especialidad de Ciudad Victoria Bicentenario 2010
• Hospital Juarez de Mexico
• Hospital Regional de Alta especialidad de Ixtapaluca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mexican Agrupation for Hematology Study
• ClinicalTrials.gov Identifier: NCT04311060
• Other Study ID Numbers: HEM-3094-19-25-1
• First Posted: Mar 17, 2020
• Last Update Posted: Mar 17, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Mar 17, 2020