Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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 [email protected]
Status Recruiting
Phase
Start date March 1, 2021
Completion date December 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04050280 - CLAG-GO for Patients With Persistent, Relapsed or Refractory AML Phase 2
Terminated NCT03951961 - Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation Phase 2
Enrolling by invitation NCT03902665 - Up-front Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients Aged 65-75 Phase 2
Recruiting NCT04752527 - Individualized Induction Therapy for Non-elderly Acute Myeloid Leukemia Patients With Adverse Risk Features Phase 2
Active, not recruiting NCT03766126 - Lentivirally Redirected CD123 Autologous T Cells in AML Phase 1
Enrolling by invitation NCT02985372 - Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia Phase 3
Recruiting NCT04240600 - Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition and VEGF in AML During Hospital Stay N/A
Recruiting NCT04425655 - Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia. Phase 2
Not yet recruiting NCT05001828 - Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia Phase 1
Recruiting NCT04454580 - Hypomethylating Agents and Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Not Eligible for Intensive Chemotherapy