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

Not yet recruiting

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT04311060
• Lead Sponsor: Mexican Agrupation for Hematology Study

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-13
• Last Update Submitted: 2020-03-13
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-17
• Study Start: 2020-03-22
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival	3 year

Trial Locations

Locations (10)

Hospital General de México; 🇲🇽 Mexico City, Mexico

Hospital Regional de Alta Especialidad Ciudad Victoria; 🇲🇽 Ciudad Victoria, Tamaulipas, Mexico

Imss Umae 25; 🇲🇽 Monterrey, Nuevo León, Mexico

Instituto Nacional de Cancerlogía; 🇲🇽 Mexico City, Mexico

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico Distrito Federal, Mexico

Hospital Regional de Alta Especialidad Bajío; 🇲🇽 León, Guanajuato, Mexico

Hospital Regional de Alta Especialidad Ixtapaluca; 🇲🇽 Ixtapaluca, Edo Mex, Mexico

Hospital Juarez de México; 🇲🇽 Mexico City, Mexico

Hospital Universitario; 🇲🇽 Monterrey, Nuevo León, Mexico

Centro Médico Naciona Siglo XXI IMSS; 🇲🇽 Mexico City, Mexico