Acute Myeloid LeukemiaLAMSANCT05558943
Study of Management and Prognosis of Patients With Acute Myeloblastic Leukemia in Saint-Antoine Hospital
An observational study of Acute Myeloid Leukemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
AML in adults represents a group of heterogeneous diseases; the prognosis remains poor despite significant therapeutic advances in recent years. In order to optimize patient care, it is necessary to have "real life" data that exhaustively reports on the patients treated in our department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 750 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2025to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients treated for AML at Saint-Antoine hospital
Who may be able to join
- Age :18 years and older
- Patients with AML
- Non objection to research
Who cannot join
- Minor patients
- Acute promyelocytic leukemia (AML3)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
AML in adults represents a group of heterogeneous diseases; the prognosis remains poor despite significant therapeutic advances in recent years. In order to optimize patient care, it is necessary to have "real life" data that exhaustively reports on the patients treated in our department. The objective of this study is:
- To describe the AML treated within the hematology department
- To optimize the management of patients with AML.
Read the detailed description
Current state of knowledge:
Acute myeloblastic leukemia are the most common leukemias in adults. This pathology is very heterogeneous. It has a poor prognosis despite numerous therapeutic advances. The lack of randomized clinical trials can make certain treatment decisions difficult. In addition, patients with comorbidities or the elderly are most often excluded from these trials even though they represent a significant proportion of new diagnoses.
Objectives:
Primary objective Evaluate the overall survival of adult patients treated for AML in our hematology department at Saint-Antoine Hospital.
Secondary objectives
- Evaluate early mortality at 30 days and 60 days post-induction
- Evaluate the CR/CRi rate after induction
- Evaluate the toxicity of the treatments
- Evaluate the relapse-free survival time
- Assess the prognostic value of JC-1 at diagnosis
- Evaluate the proportion of patients eligible for intensive treatment and/or allograft
- Evaluate the side effects of the treatments undertaken
- Describe the molecular and cytogenetic characteristics of hemopathies at diagnosis and at relapse
Duration of study:
Retrospective cohort (cohort A): patients diagnosed between junuary1,2010 and May 30,2022 Prospective cohort (cohort B): patients diagnosed between June 1, 2022 and December 31, 2023. A follow-up of 2 years will be necessary after the end of treatment.
The end of follow-up is estimated at December 2025 for the entire cohort.
Data collection:
Collection of clinical and biological data in the patient's medical file via the Orbis software
Population:
Adult patients treated for AML at Saint-Antoine hospital
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Prognosis of Acute myeloblastic leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2 years after diagnosis
Secondary outcomes (7)
Overall survival
Measured: 6 months after diagnosis
Overall survival
Measured: 1 year after diagnosis
Cytological remission rate
Measured: after the phase of induction up to 24 months
Incomplete cytological remission rate
Measured: after the phase of induction up to 24 months
Leukemia free survival rate
Measured: 24 months
Side effects
according to the CTCAE v5.0 classification
Measured: 24 months
the rate of patients receiving intensive treatment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study startOct 2025 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis GENTHON, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558943
- Sponsor's protocol ID
- APHP211337
- Acronym
- LAMSA
- Status last verified
- Apr 2025
- First submitted
- 10 Jun 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Management and Prognosis of Patients With Acute Myeloblastic Leukemia in Saint-Antoine Hospital
- ClinicalTrials.gov ID
- NCT05558943
- Acronym / sponsor ID
- LAMSA / APHP211337
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Prognosis of Acute myeloblastic leukemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 28 Sep 2022 (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.
AML in adults represents a group of heterogeneous diseases; the prognosis remains poor despite significant therapeutic advances in recent years. In order to optimize patient care, it is necessary to have "real life" data that exhaustively reports on the patients treated in our department. The objective of this study is:
- To describe the AML treated within the hematology department
- To optimize the management of patients with AML.
Detailed description
Current state of knowledge:
Acute myeloblastic leukemia are the most common leukemias in adults. This pathology is very heterogeneous. It has a poor prognosis despite numerous therapeutic advances. The lack of randomized clinical trials can make certain treatment decisions difficult. In addition, patients with comorbidities or the elderly are most often excluded from these trials even though they represent a significant proportion of new diagnoses.
Objectives:
Primary objective Evaluate the overall survival of adult patients treated for AML in our hematology department at Saint-Antoine Hospital.
Secondary objectives
- Evaluate early mortality at 30 days and 60 days post-induction
- Evaluate the CR/CRi rate after induction
- Evaluate the toxicity of the treatments
- Evaluate the relapse-free survival time
- Assess the prognostic value of JC-1 at diagnosis
- Evaluate the proportion of patients eligible for intensive treatment and/or allograft
- Evaluate the side effects of the treatments undertaken
- Describe the molecular and cytogenetic characteristics of hemopathies at diagnosis and at relapse
Duration of study:
Retrospective cohort (cohort A): patients diagnosed between junuary1,2010 and May 30,2022 Prospective cohort (cohort B): patients diagnosed between June 1, 2022 and December 31, 2023. A follow-up of 2 years will be necessary after the end of treatment.
The end of follow-up is estimated at December 2025 for the entire cohort.
Data collection:
Collection of clinical and biological data in the patient's medical file via the Orbis software
Population:
Adult patients treated for AML at Saint-Antoine hospital
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated for AML at Saint-Antoine hospital
Key inclusion criteria (3 listed)
- Age :18 years and older
- Patients with AML
- Non objection to research
Key exclusion criteria (2 listed)
- Minor patients
- Acute promyelocytic leukemia (AML3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 2 years after diagnosis
7 secondary outcomes
Overall survival
Time frame: 6 months after diagnosis
Overall survival
Time frame: 1 year after diagnosis
Cytological remission rate
Time frame: after the phase of induction up to 24 months
Incomplete cytological remission rate
Time frame: after the phase of induction up to 24 months
Leukemia free survival rate
Time frame: 24 months
Side effects
Time frame: 24 months
the rate of patients receiving intensive treatment
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Alexis GENTHON, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site 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, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 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: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis GENTHON, MD (01 49 28 53 44, alexis.genthon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years after diagnosis). 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 2 Apr 2025.