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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04311060
Other study ID # HEM-3094-19-25-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 22, 2020
Est. completion date October 31, 2025

Study information

Verified date March 2020
Source Mexican Agrupation for Hematology Study
Contact Roberta Demichelis, MD
Phone +521555487 0900
Email robertademichelis@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 31, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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


Intervention

Diagnostic Test:
Molecular panel
Detection of CBF rearrangements using PCR: CBFB-MYH11 [inv(16)(p13;q22), isoforms A, E and D; AML-ETO (RUNX1-RUNX1T1) (t8;21)(q22;q22). NGS panel to detect classic mutations in: FLT3-ITD and TKD, NPM1, CEBPA, RUNX1, TP53, ASXL1, IDH1, IDH2 and KIT

Locations

Country Name City State
Mexico Hospital Regional de Alta Especialidad Ciudad Victoria Ciudad Victoria Tamaulipas
Mexico Hospital Regional de Alta Especialidad Ixtapaluca Ixtapaluca Edo Mex
Mexico Hospital Regional de Alta Especialidad Bajío León Guanajuato
Mexico Centro Médico Naciona Siglo XXI IMSS Mexico City
Mexico Hospital General de México Mexico City
Mexico Hospital Juarez de México Mexico City
Mexico Instituto Nacional de Cancerlogía Mexico City
Mexico Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico Distrito Federal
Mexico Hospital Universitario Monterrey Nuevo León
Mexico Imss Umae 25 Monterrey Nuevo León

Sponsors (11)

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

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival 3 year
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