Study of Management and Prognosis of Patients With Acute Myeloblastic Leukemia in Saint-Antoine Hospital (LAMSA)
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|ClinicalTrials.gov Identifier: NCT05558943|
Recruitment Status : Not yet recruiting
First Posted : September 28, 2022
Last Update Posted : September 28, 2022
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.
|Condition or disease|
|Acute Myeloid Leukemia|
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.
Primary objective Evaluate the overall survival of adult patients treated for AML in our hematology department at Saint-Antoine Hospital.
- 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.
Collection of clinical and biological data in the patient's medical file via the Orbis software
Adult patients treated for AML at Saint-Antoine hospital
|Study Type :||Observational|
|Estimated Enrollment :||750 participants|
|Official Title:||Study of Management and Prognosis of Patients With Acute Myeloblastic Leukemia in Saint-Antoine Hospital|
|Estimated Study Start Date :||October 2022|
|Estimated Primary Completion Date :||June 2026|
|Estimated Study Completion Date :||June 2026|
- Overall survival [ Time Frame: 2 years after diagnosis ]
- 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 ]according to the CTCAE v5.0 classification
- the rate of patients receiving intensive treatment [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558943
|Contact: Alexis GENTHON, MD||01 49 28 53 email@example.com|
|Department of Hematology, Hospital Saint Antoine|
|Paris, France, 75012|
|Principal Investigator:||Alexis GENTHON, MD||Assistance Publique - Hôpitaux de Paris|