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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date June 10, 2022
First Posted Date September 28, 2022
Last Update Posted Date September 28, 2022
Estimated Study Start Date October 2022
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2022)
Overall survival [ Time Frame: 2 years after diagnosis ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 26, 2022)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Management and Prognosis of Patients With Acute Myeloblastic Leukemia in Saint-Antoine Hospital
Official Title Study of Management and Prognosis of Patients With Acute Myeloblastic Leukemia in Saint-Antoine Hospital
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients treated for AML at Saint-Antoine hospital
Condition Acute Myeloid Leukemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 26, 2022)
750
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2026
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Minor patients
  • Acute promyelocytic leukemia (AML3)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Alexis GENTHON, MD 01 49 28 53 44 alexis.genthon@aphp.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT05558943
Other Study ID Numbers APHP211337
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Same as current
Current Study Sponsor Assistance Publique - Hôpitaux de Paris
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Alexis GENTHON, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date September 2022