Acute Myeloid Leukemia, AdultNCT05127798
RWE of 1st Line Treatment in Adults With AML From 18 to 70 Years Old.
An observational study of Acute Myeloid Leukemia, Adult, run by Grupo Argentino de Tratamiento de la Leucemia Aguda at 2 sites in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia, Adult
- What is being tested?
- Evaluation of first line treatment with intensive treatment outcome in adult patients with AML.
- How many people
- 50 participants
- Where
- 2 sitesArgentina
- Study dates
- 1 Mar 2021to 1 Dec 2024
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients between 18 and 70 years old with AML in first line treatment
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites, 2 recruiting
- Recruiting
FUNDALEU
CABA
Isolda Fernandez, Dr., ifernandez@fundaleu.org.ar
- Recruiting
Hospital Italiano de La Plata
La Plata, Buenos Aires
Hernán Dick, Dr., hdick@italianolaplata.org.ar
About this study
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
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia, Adult
- Being tested
- Evaluation of first line treatment with intensive treatment outcome in adult patients with AML.
- Keywords
- Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Evaluation of first line treatment with intensive treatment outcome in adult patients with AML. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 36 months
Evaluate the toxicity of the scheme measured by type, frequency, severity and relation to treatment of adverse events.
Measured: 36 months
Evaluate treatment-related mortality (within 30 days of admission).
Measured: Within 30 days of admission
Evaluate the role of measurable residual disease (MRD) in terms of EFS prior to each consolidation.
Measured: 36 months
Evaluate the role of allogeneic stem cell transplantation in terms of EFS in intermediate and adverse risk patients.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Grupo Argentino de Tratamiento de la Leucemia Aguda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Jose Mela Osorio, Dr., Principal investigator, Grupo Argentino de Tratamiento de la Leucemia AgudaHernan Dick, Dr., Principal investigator, Grupo Argentino de Tratamiento de la Leucemia AgudaIsolda Fernandez, Dr., Study chair, Grupo Argentino de Tratamiento de la Leucemia Aguda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127798
- Sponsor's protocol ID
- GATLA 10-LMA-20
- Status last verified
- Nov 2021
- First submitted
- 9 Nov 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share study protocol
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05127798
- Acronym / sponsor ID
- GATLA 10-LMA-20
- Conditions
- Acute Myeloid Leukemia, Adult
- Keywords
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Grupo Argentino de Tratamiento de la Leucemia AgudaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult from 18 to 70 years old AML in first line | – | Other: Evaluation of first line treatment with intensive treatment outcome in adult patients with AML.Patients >/= 18 years old with recent diagnosis of AML who receive treatment with intensive chemotherapy according to our local guidelines. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients between 18 and 70 years old with AML in first line treatment
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Adult from 18 to 70 years old AML in first line |
Primary outcome
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
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.
5 secondary outcomes
Evaluate the Complete Remission Rate with negative measurable residual disease (MRD) determined by CMF at the end of induction treatment.
Time frame: 36 months
Evaluate the toxicity of the scheme measured by type, frequency, severity and relation to treatment of adverse events.
Time frame: 36 months
Evaluate treatment-related mortality (within 30 days of admission).
Time frame: 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
Evaluate the role of allogeneic stem cell transplantation in terms of EFS in intermediate and adverse risk patients.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: Yes. Share study protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Jose Mela Osorio, Dr. principal investigator
Grupo Argentino de Tratamiento de la Leucemia Aguda
Hernan Dick, Dr. principal investigator
Grupo Argentino de Tratamiento de la Leucemia Aguda
Isolda Fernandez, Dr. study chair
Grupo Argentino de Tratamiento de la Leucemia Aguda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, Adult, run by Grupo Argentino de Tratamiento de la Leucemia Aguda at 2 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Jose Mela Osorio, Dr. (541148771000, mjmela@fundaleu.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.