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

November 9, 2021 updated by: Grupo Argentino de Tratamiento de la Leucemia Aguda

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients between 18 and 70 years old with AML in first line treatment

Description

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.
  • Any other condition, such as age or associated pathology that contraindicates treatment with intensive chemotherapy, especially with anthracyclines. Any patient who does not meet the inclusion and exclusion criteria for treatment with intensive chemotherapy may be evaluated on an individual basis if it is considered that they could still benefit from this treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the Overall Survival of patients diagnosed with primary or secondary AML between 18 and 70 years of age treated in first line with intensive chemotherapy regimens and risk-adapted consolidation.
Time Frame: 36 months
Evaluate overall survival of patients diagnosed with AML and treated in first line with intensive chemotherapy combined with different consolidation modalities depending on risk category
36 months
Evaluate the Event Free Survival of patients diagnosed with primary or secondary AML between 18 and 70 years of age treated in first line with intensive chemotherapy regimens and risk-adapted consolidation.
Time Frame: 36 months
Evaluate the Event Free Survival of patients diagnosed with AML and treated in first line with intensive chemotherapy combined with different consolidation modalities depending on risk category.
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the Complete Remission Rate with negative measurable residual disease (MRD) determined by CMF at the end of induction treatment.
Time Frame: 36 months
36 months
Evaluate the toxicity of the scheme measured by type, frequency, severity and relation to treatment of adverse events.
Time Frame: 36 months
36 months
Evaluate treatment-related mortality (within 30 days of admission).
Time Frame: Within 30 days of admission
Within 30 days of admission
Evaluate the role of measurable residual disease (MRD) in terms of EFS prior to each consolidation.
Time Frame: 36 months
36 months
Evaluate the role of allogeneic stem cell transplantation in terms of EFS in intermediate and adverse risk patients.
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Argentino de Tratamiento de la Leucemia Aguda

Investigators

  • Principal Investigator: María José Mela Osorio, Dr., Grupo Argentino de Tratamiento de la Leucemia Aguda
  • Study Chair: Isolda Fernández, Dr., Grupo Argentino de Tratamiento de la Leucemia Aguda
  • Principal Investigator: Hernan Dick, Dr., Grupo Argentino de Tratamiento de la Leucemia Aguda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GATLA 10-LMA-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Share study protocol

IPD Sharing Time Frame

The data is available since June 2021, and will remain available until the end of the clinical trial.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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