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Study of Management and Prognosis of Patients With Acute Myeloblastic Leukemia in Saint-Antoine Hospital (LAMSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05558943
Recruitment Status : Not yet recruiting
First Posted : September 28, 2022
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. 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

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

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Other
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





Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years after diagnosis ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 6 months after diagnosis ]
  2. Overall survival [ Time Frame: 1 year after diagnosis ]
  3. Cytological remission rate [ Time Frame: after the phase of induction up to 24 months ]
  4. Incomplete cytological remission rate [ Time Frame: after the phase of induction up to 24 months ]
  5. Leukemia free survival rate [ Time Frame: 24 months ]
  6. Side effects [ Time Frame: 24 months ]
    according to the CTCAE v5.0 classification

  7. the rate of patients receiving intensive treatment [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients treated for AML at Saint-Antoine hospital
Criteria

Inclusion Criteria:

  • Age :18 years and older
  • Patients with AML
  • Non objection to research

Exclusion Criteria:

  • Minor patients
  • Acute promyelocytic leukemia (AML3)

Information from the National Library of Medicine

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


Contacts
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Contact: Alexis GENTHON, MD 01 49 28 53 44 alexis.genthon@aphp.fr

Locations
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France
Department of Hematology, Hospital Saint Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Alexis GENTHON, MD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05558943    
Other Study ID Numbers: APHP211337
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Prognosis of Acute myeloblastic leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid