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RWE of 1st Line Treatment in Adults With AML From 18 to 70 Years Old.

NCT ID: NCT05127798

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-12-01

Brief Summary

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This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of Acute Myeloid Leukemia (AML) patients in the first line with intensive chemotherapy based regimens in Argentina.

Detailed Description

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The purpose of this trial is to gather real world evidence of the characteristics of AML patients in Argentina who receive intensive chemotherapy based treatment in first line following our national guidelines. The study primary endpoint is to evaluate event free survival (EFS) and overall survival (OS) of patients diagnosed with AML and treated in first line with intensive chemotherapy combined with different consolidation modalities depending on risk category. Secondary endpoints are to evaluate EFS and OS according to: cytogenetic and molecular classification, measurable residual disease (MRD) (by flow cytometry) post induction. Assess treatment-related mortality and limitations in completing treatment due to toxicity. Evaluate the role of allogeneic stem cell transplantation in terms of EFS in intermediate and adverse risk patients.

Every AML patient diagnosed in our institutions will follow our guidelines with respect to diagnosis procedures. Risk category will depend on molecular and cytogenetic features according to European Leukemia net 2017 risk stratification.

All patients will receive induction with 7+3 scheme; if CR is not met induction will be followed by a reinduction with FLAG-IDA. According to post induction remission status and risk assessment, consolidation will consist of three courses of cytarabine (2g/m2) + daunorubicin (60mg/m2) for low risk group; or consolidation with cytarabine (2g/m2) + daunorubicin (60mg/m2) followed by allogeneic stem cell transplantation for intermediate and adverse risk groups.

Patients harboring Flt3 mutation will add midostaurin during induction and consolidations: midostaurin 50 mg orally every 12 hours on days 8-21 of each 28-day cycle.

In the cases of Coring Binding Factor AML and NPM1 mutated AML, molecular MRD assessment will be done at the end of consolidations by RQ-PCR and thereafter a follow-up RQ-PCR evaluation every 3 months during the first two years.

Conditions

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Acute Myeloid Leukemia, Adult

Keywords

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult from 18 to 70 years old AML in first line

Patients \>/= 18 years old with recent diagnosis of AML who receive treatment with intensive chemotherapy according to our local guidelines.

Evaluation of first line treatment with intensive treatment outcome in adult patients with AML.

Intervention Type OTHER

Evaluation of first line treatment with intensive treatment outcome (or event free survival and overall survival and toxicity) in adult patients between 18 and 70 years old with AML.

Interventions

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Evaluation of first line treatment with intensive treatment outcome in adult patients with AML.

Evaluation of first line treatment with intensive treatment outcome (or event free survival and overall survival and toxicity) in adult patients between 18 and 70 years old with AML.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years or older.
* Patients with AML (de novo or secondary to MDS or previous treatment) who meet the diagnostic criteria according to WHO 2016 classification.
* Signature of the form consent for participation in the study.

Exclusion Criteria

* Men and women, \<18 or \>70 years of age.
* Patients with chronic myeloid leukemia blast crisis or transformation to acute leukemia of other myeloproliferative syndromes.
* Patients with relapsed AML.
* Acute promyelocytic leukemia t(15; 17) or variants.
* Absence of written informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 that is not due to the disease that motivates the treatment (AML).
* Transplant Comorbidity Index (HCT-CI) \>3.
* Left ventricular ejection fraction \< 40% by echocardiogram (Simpsom).
* Bilirubin, alkaline phosphatase or alanine aminotransferase \> 3 times the upper normal limit not due to AML.
* Serum creatinine ≥ 2.5 mg/dL not due to AML.
* Positive pregnancy test or absence of effective methods of contraception in women of childbearing age.
* Presence of active neoplasia other than AML whose treatment is more urgent at the discretion of the treating physicians.
* Presence of serious psychiatric illness.
* Known history of infection with human immunodeficiency virus (HIV). Active uncontrolled Hepatitis C or Active uncontrolled Hepatitis B.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo Argentino de Tratamiento de la Leucemia Aguda

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Jose Mela Osorio, Dr.

Role: PRINCIPAL_INVESTIGATOR

Grupo Argentino de Tratamiento de la Leucemia Aguda

Hernan Dick, Dr.

Role: PRINCIPAL_INVESTIGATOR

Grupo Argentino de Tratamiento de la Leucemia Aguda

Isolda Fernandez, Dr.

Role: STUDY_CHAIR

Grupo Argentino de Tratamiento de la Leucemia Aguda

Locations

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Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Site Status RECRUITING

FUNDALEU

CABA, , Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Maria Jose Mela Osorio, Dr.

Role: CONTACT

Phone: 541148771000

Email: [email protected]

Paula Freigeiro

Role: CONTACT

Phone: 5491140470052

Email: [email protected]

Facility Contacts

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Hernán Dick, Dr.

Role: primary

Isolda Fernandez, Dr.

Role: primary

Other Identifiers

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GATLA 10-LMA-20

Identifier Type: -

Identifier Source: org_study_id