NCT04311060

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

March 22, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

5.5 years

First QC Date

March 13, 2020

Last Update Submit

March 13, 2020

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3 year

Interventions

Molecular panelDIAGNOSTIC_TEST

* 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

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mexican adults with newly diagnosed AML who are candidates for treatment (intensive or not intensive)

You may qualify if:

  • Newly diagnosed AML
  • Over 15 years of age
  • Flow cytometry confirmation
  • Candidate for treatment (intensive or not intensive)

You may not qualify if:

  • Acute Promyelocytic Leukemia
  • Mixed phenotype leukemias
  • Isolated myeloid sarcoma
  • Blastic plasmacytoid dendritic cell neoplasm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hospital Regional de Alta Especialidad Ixtapaluca

Ixtapaluca, Edo Mex, Mexico

Location

Hospital Regional de Alta Especialidad Bajío

León, Guanajuato, Mexico

Location

Hospital Universitario

Monterrey, Nuevo León, Mexico

Location

Imss Umae 25

Monterrey, Nuevo León, Mexico

Location

Hospital Regional de Alta Especialidad Ciudad Victoria

Ciudad Victoria, Tamaulipas, Mexico

Location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 1400, Mexico

Location

Centro Médico Naciona Siglo XXI IMSS

Mexico City, Mexico

Location

Hospital General de México

Mexico City, Mexico

Location

Hospital Juarez de México

Mexico City, Mexico

Location

Instituto Nacional de Cancerlogía

Mexico City, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow samples

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Roberta Demichelis, MD

CONTACT

+521555487 0900robertademichelis@gmail.com

Emmanuel Almanza Huante, MD

CONTACT

ealmanza.huante@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 17, 2020

Study Start

March 22, 2020

Primary Completion

September 30, 2025

Study Completion

October 31, 2025

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

ME(10)