Epidemiological Study of a Prospective Cohort of Patients Aged 60 and Over Managed for Acute Myeloid Leukemia (AML) and Receiving Intensive Induction Therapy

Обзор

This observational epidemiological study targets patients aged 60 and over with de novo or secondary acute myeloblastic leukemia suitable for intensive receive intensive induction therapy as defined by the group. The main aim of the study is to determine the epidemiological characteristics of AML patients, both clinically and biologically, and to correlate these to their outcome. The incidence of AML increases with age, exponentially after the age of 50, giving a median age at diagnosis of close to 70 years, with over half of patients half of patients are over 60 at diagnosis. The principle of treatment as in younger patients, is based on trying to achieve complete remission (CR). remission (CR). Observed complete remission rates range from 38 to 70%. Long-term survival of elderly subjects remains limited, at around 10 to 15%, despite the various types of consolidation tried out in recent years. years. However, intensive chemotherapy remains the preferred option for initial treatment of these hematological diseases when general condition and comorbidities allow. As shown by Swedish registry studies, it is associated with improved life expectancy. The proportion of patients who can receive intensive initial treatment is not well known in France, probably varies widely from one region to another, and certainly decreases with increasing age. Only the registry studies currently underway will enable us to assess this precisely.

Первичные конечные точки

• describe the initial characteristics of Acute myeloid leukemia (AML) in patients aged 60 years and older [Срок оценки: at diagnosis (from first results related to AML until AML diagnosis) 3 months]
• describe the initial characteristics of Acute myeloid leukemia (AML) in patients aged 60 years and older [Срок оценки: at diagnosis (from first results related to AML until AML diagnosis) 3 months]
• Describe first line AML treatment received [Срок оценки: 12 months]
• characterize the Overall survival (OS) [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Patients aged 60 and over
• Patients with previously untreated de novo or secondary AML
• Patients suitable for standard intensive treatment
• Patients who have read the information document and agreed to the collection of data concerning them (signature of informed consent).

Критерии исключения

• Patients with AML 3
• Patients with severe, uncontrolled infection at the time of inclusion
• Patients with psychiatric or social disorders that will prevent compliance with the protocol
• Patients without health insurance (affiliation to a social security scheme)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 27 центров

• Angers CHU — Angers
• Annecy CH — Annecy
• Avignon CH — Avignon
• Bayonne CH — Bayonne
• Besançon CHU — Besançon
• Brest CHU — Brest
• CHU Estaing — Clermont-Ferrand
• Colmar CH — Colmar
• … и ещё 19 центров

Идентификаторы

NCT: NCT06891144 · FILObs_LAMSA 2013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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