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

NCT05127798 | Unknown

• 1 other identifier: GATLA 10-LMA-20
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Acute Myeloid Leukemia, Adult

Keywords

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 Outcomes (5)

• Evaluate the Complete Remission Rate with negative measurable residual disease (MRD) determined by CMF at the end of induction treatment.

  36 months

• Evaluate the toxicity of the scheme measured by type, frequency, severity and relation to treatment of adverse events.

  36 months

• Evaluate treatment-related mortality (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.

  36 months

• Evaluate the role of allogeneic stem cell transplantation in terms of EFS in intermediate and adverse risk patients.

  36 months

Study Arms (1)

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.

Interventions

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

Adult from 18 to 70 years old AML in first line

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo Argentino de Tratamiento de la Leucemia Aguda: lead

Study Sites (2)

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

RECRUITING

FUNDALEU

CABA, Argentina

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Maria Jose Mela Osorio, Dr.

  Grupo Argentino de Tratamiento de la Leucemia Aguda

  PRINCIPAL INVESTIGATOR

• Hernan Dick, Dr.

  Grupo Argentino de Tratamiento de la Leucemia Aguda

  PRINCIPAL INVESTIGATOR

• Isolda Fernandez, Dr.

  Grupo Argentino de Tratamiento de la Leucemia Aguda

  STUDY CHAIR

Central Study Contacts

Maria Jose Mela Osorio, Dr.

CONTACT

541148771000; mjmela@fundaleu.org.ar

Paula Freigeiro

CONTACT

5491140470052; gatla.ar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 19, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data is available since June 2021, and will remain available until the end of the clinical trial.

Locations

AR (2)