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

• ClinicalTrials.gov Identifier: NCT05558943
• Recruitment Status: Not yet recruiting
• First Posted: September 28, 2022
• Last Update Posted: September 28, 2022
• Sponsor: Assistance Publique - Hôpitaux de Paris
• 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

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

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