Acute Myeloid LeukemiaNCT04311060
Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicentric Study.
An observational study of Acute Myeloid Leukemia, run by Mexican Agrupation for Hematology Study at 10 sites in Mexico.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Molecular panel
- How many people
- 100 participants
- Where
- 10 sitesMexico
- Study dates
- 22 Mar 2020to 31 Oct 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mexican adults with newly diagnosed AML who are candidates for treatment (intensive or not intensive)
Who may be able to join
- Newly diagnosed AML
- Over 15 years of age
- Flow cytometry confirmation
- Candidate for treatment (intensive or not intensive)
Who cannot join
- Acute Promyelocytic Leukemia
- Mixed phenotype leukemias
- Isolated myeloid sarcoma
- Blastic plasmacytoid dendritic cell neoplasm
Trial locations and contacts
10 sites in 1 country.
Emmanuel Almanza Huante, MD contact
10 sites in 1 country
Mexico10 sites
Hospital Regional de Alta Especialidad Ciudad Victoria
Ciudad Victoria, Tamaulipas
Ramón A Martínez Hernández, MD
Hospital Regional de Alta Especialidad Ixtapaluca
Ixtapaluca, Edo Mex
Alvaro Cabrera García, MD
Hospital Regional de Alta Especialidad Bajío
León, Guanajuato
Lauro Fabián Amador Medina, MD
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 1400
Centro Médico Naciona Siglo XXI IMSS
Mexico City
Sue Cynthia Gómez Cortes, MD
Hospital General de México
Mexico City
Efreen Montaño Figueroa, MD
Hospital Juarez de México
Mexico City
Andrea Milan Salvatierra, MD
Instituto Nacional de Cancerlogía
Mexico City
Silvia Rivas Vera, MD
Hospital Universitario
Monterrey, Nuevo León
Andrés Gómez, MD
Imss Umae 25
Monterrey, Nuevo León
Diego Cruz Contreras, MD
About this study
Official title: Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicenter Study
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
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Molecular panel
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start22 Mar 2020 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Mexican Agrupation for Hematology Study
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311060
- Sponsor's protocol ID
- HEM-3094-19-25-1
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT04311060
- Acronym / sponsor ID
- HEM-3094-19-25-1
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mexican Agrupation for Hematology StudyUniversity, hospital or other
- Collaborators
- 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
- Study start
- 22 Mar 2020 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mexican adults with newly diagnosed AML who are candidates for treatment (intensive or not intensive)
Key inclusion criteria (4 listed)
- Newly diagnosed AML
- Over 15 years of age
- Flow cytometry confirmation
- Candidate for treatment (intensive or not intensive)
Key exclusion criteria (4 listed)
- Acute Promyelocytic Leukemia
- Mixed phenotype leukemias
- Isolated myeloid sarcoma
- Blastic plasmacytoid dendritic cell neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | – |
Primary outcome
overall survival
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Almanza Huante, MD contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Mexican Agrupation for Hematology Study at 10 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberta Demichelis, MD (+521555487 0900 ext. 2700, robertademichelis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.