ObServatory Children Acute RElated Therapy Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-09-01

Brief Summary

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Acute Myeloid Leukemias (AML) of the child are a rare disease and its prognosis varies according to the subgroup. Secondary AMLs remain a subgroup of poor prognosis, whose cytogenetic and molecular characteristics and prognostic value differ in part from de novo AMLs. The purpose of this national observatory is to record scientific and medical information on cases of secondary AML that have occurred in France since 2013 in order to improve the treatment of children and adolescents with this disease in the years to come. This national observatory will contribute to better knowledge and progress in research into these diseases.

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Detailed Description

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Therapy-related myeloid neoplasms (t-MNs) are a group of hematologic diseases that arise after chemotherapy and/or radiation therapy for a previous cancer or rarely autoimmune diseases. t-MNs had been included in the group of AMLs and remain as a distinct category also in the recent 2016 revision of the WHO classification of myeloid neoplasm and acute leukemia. The latency between exposition to anticancer drugs and development of t-MN may vary from some months up to 10 years, even considering the age at diagnosis of the primary malignancy, the kind of cytotoxic treatment previously used, and the cumulative dose and dose intensity. The prognosis of s-AML is generally considered to be poorer than that of de novo AML. The disease tends to be refractory to chemotherapy, and patients' tolerance of treatment generally is reduced because of prior therapies. 5-year event-free survival (EFS) and overall survival (OS) rates of pediatric t-AML/t-MDS have been reported to be 14% to 30%. However, the results are conflicting and overall lacking when compared with those in adults. The purpose of this national observatory is to record scientific and medical information on cases of secondary Acute Myeloid Leukemias that have occurred in France since 2013 in order to improve the treatment of children and adolescents with this disease in the years to come. The primary objective is to evaluate the association of potential prognostic factors (including clinical-biological factors) with the overall survival of children and adolescents aged 0-18 years diagnosed with secondary AML. The secondary objectives are to test the feasibility of setting up a French national database of secondary AMLs for children and adolescents as a first step towards European implementation, to assess the association of potential prognostic factors with event free survival and the occurrence of treatment-related toxicities, to characterize the molecular abnormalities associated with secondary AMLs in children and adolescents.

Conditions

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Leukemia, Myeloid, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Secondary Acute Myeloid Leukemias (AML) of the child

collection of the clinical and biological characteristics of secondary AMLs in children

Intervention Type OTHER

to record scientific and medical information on cases of secondary Acute Myeloid Leukemias that have occurred in France since 2013

Interventions

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collection of the clinical and biological characteristics of secondary AMLs in children

to record scientific and medical information on cases of secondary Acute Myeloid Leukemias that have occurred in France since 2013

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged 0-18 years
* Patient with first cancer
* Diagnosis of secondary AML
* Patients treated in a SFCE (Société française des cancers de l'enfant) center
* For cases included in the prospective from March 2019 onwards: Consent of holders of parental authority and consent of the child of understanding age

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No