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

Acute Myeloid Leukemia, Adult Clinical Trial

Official title: Real World Evidence of First Line Treatment With Intensive Chemotherapy in Adult Patients With Acute Myeloid Leukemia From 18 to 70 Years Old

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia, Adult
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

• NCT number: NCT05127798
• Study type: Observational [Patient Registry]
• Source: Grupo Argentino de Tratamiento de la Leucemia Aguda
• Contact: Maria Jose Mela Osorio, Dr.
• Phone: 541148771000
• Email: mjmela@fundaleu.org.ar
• Status: Recruiting
• Start date: March 1, 2021
• Completion date: December 1, 2024