Leukemia, Myeloid, AcuteOSCARENCT04450784
ObServatory Children Acute RElated Therapy Leukemia
An observational study of Leukemia, Myeloid, Acute, run by University Hospital, Bordeaux.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- collection of the clinical and biological characteristics of secondary AMLs in children
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children and adolescents aged 0-18 years diagnosed with secondary AML
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
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
- Leukemia, Myeloid, Acute
- Being tested
- collection of the clinical and biological characteristics of secondary AMLs in children
- Keywords
- Secondary, Acute myeloid Leukemia, Children
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of the clinical and biological characteristics of secondary AMLs in childrenOther
to record scientific and medical information on cases of secondary Acute Myeloid Leukemias that have occurred in France since 2013
| Study group | Role | What they receive |
|---|---|---|
| Secondary Acute Myeloid Leukemias (AML) of the child | Not described Receives: Other: collection of the clinical and biological characteristics of secondary AMLs in children |
What is being measured
The primary outcome is the main question the study is designed to answer.
potential clinical-biological prognostic factors - patient characterics
patient characteristics are sex, patient's age at the start of treatment for secondary AML, date of birth, personal history of genetic predisposition (including brittle diseases - see below), family history of cancers (1st or 2nd degree)
Measured: through study completion, an average of 6 months
potential clinical-biological prognostic factors - first cancer characteristics
First cancer characteristics are age of onset, determined from the date of diagnosis, and histology, determined by anatomo-pathological diagnosis.
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors :first cancer treatment : types of treatments received
type of treatment: chemotherapy (Anthracyclines, Alkylating agents) and / or radiotherapy and/or Marrow autograft or allograft
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - first cancer treatments: response to treatment
response measured by bone marrow assessment using morphology and minimal residual disease (MRD) assessment : no response, partial response, complete remission
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - first cancer treatments: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
nature, incidence and severity of adverse events (AEs)
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - first cancer treatments: duration of treatment
duration of treatment determined from the start and end dates
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - first cancer treatments: cumulative dose received
cumulative dose of each type of treatment received ( chemotherapy (Anthracyclines, Alkylating agents) and / or radiotherapy and/or Marrow autograft or allograft)
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - secondary AML characteristics: date of diagnosis
date of diagnosis
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - secondary AML characteristics: median time of onset compared to the date of end of treatment for the 1st cancer
median time of onset compared to the date of end of treatment for the 1st cancer
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - secondary AML characteristics : hematological data assessed by morphology
Leukocytes at diagnosis of secondary AML (G/L)
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - secondary AML characteristics: cytogenetic data
karyotype, exclusive and cumulative anomalies
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - secondary AML characteristics: molecular data
molecular data assessed by Next-Generation Sequencing panel
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - secondary AML treatment: duration of treatment
duration of treatment determined from the start and end dates
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - secondary AML treatment: type of treatment
chemotherapy received and bone marrow transplantation
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - secondary AML treatment : response to treatment
response measured by bone marrow assessment using morphology and minimal residual disease (MRD) assessment : no response, partial response, complete remission
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - secondary AML treatment: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
nature, incidence and severity of adverse events (AEs)
Measured: through study completion, an average of 6 months after patient inclusion
potential clinical-biological prognostic factors - Overall Survival (OS)
Evaluated as time from diagnostic of the second AML to death from any cause or date last seen for patients who are alive at the end of the trial
Measured: at the end of the 2 years of the inclusion period
Secondary outcomes (5)
feasibility of setting up a French national database of secondary AMLs for children and adolescents - Number of cases included over the period
Number of cases included over the period
Measured: at the end of the 2 years of the inclusion period
feasibility of setting up a French national database of secondary AMLs for children and adolescents - Missing Data
Proportion and type of missing data in the database after the base freeze
Measured: at the end of the 2 years of the inclusion period
feasibility of setting up a French national database of secondary AMLs for children and adolescents - Centre participation rates
Centre participation rates
Measured: at the end of the 2 years of the inclusion period
association of potential prognostic factors with event free survival and the occurrence of treatment-related toxicities- Recurrence of the disease
Recurrence of the disease : Relapse criteria (in a patient who has had complete remission):
≥ 5% blasts in the bone marrow (not attributable to post chemotherapy regeneration)
Measured: at the end of the 2 years of the inclusion period
association of potential prognostic factors with event free survival and the occurrence of treatment-related toxicities- Treatment-related toxicities
Treatment-related toxicities : Metabolic / endocrine complications in particular: growth retardation, hypothyroidism, gonadal insufficiency; Organic complications, in particular: renal failure, heart failure, respiratory failure ; Graft versus host reaction (GvH)
Measured: at the end of the 2 years of the inclusion period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450784
- Sponsor's protocol ID
- CHUBX 2018/31
- Acronym
- OSCARE
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ObServatory Children Acute RElated Therapy Leukemia
- ClinicalTrials.gov ID
- NCT04450784
- Acronym / sponsor ID
- OSCARE / CHUBX 2018/31
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- Secondary, Acute myeloid Leukemia, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secondary Acute Myeloid Leukemias (AML) of the child | – | Other: collection of the clinical and biological characteristics of secondary AMLs in children |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children and adolescents aged 0-18 years diagnosed with secondary AML
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of the clinical and biological characteristics of secondary AMLs in childrento record scientific and medical information on cases of secondary Acute Myeloid Leukemias that have occurred in France since 2013 | Other | Secondary Acute Myeloid Leukemias (AML) of the child |
Primary outcome
potential clinical-biological prognostic factors - patient characterics
Time frame: through study completion, an average of 6 months
patient characteristics are sex, patient's age at the start of treatment for secondary AML, date of birth, personal history of genetic predisposition (including brittle diseases - see below), family history of cancers (1st or 2nd degree)
potential clinical-biological prognostic factors - first cancer characteristics
Time frame: through study completion, an average of 6 months after patient inclusion
First cancer characteristics are age of onset, determined from the date of diagnosis, and histology, determined by anatomo-pathological diagnosis.
potential clinical-biological prognostic factors :first cancer treatment : types of treatments received
Time frame: through study completion, an average of 6 months after patient inclusion
type of treatment: chemotherapy (Anthracyclines, Alkylating agents) and / or radiotherapy and/or Marrow autograft or allograft
potential clinical-biological prognostic factors - first cancer treatments: response to treatment
Time frame: through study completion, an average of 6 months after patient inclusion
response measured by bone marrow assessment using morphology and minimal residual disease (MRD) assessment : no response, partial response, complete remission
potential clinical-biological prognostic factors - first cancer treatments: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 6 months after patient inclusion
nature, incidence and severity of adverse events (AEs)
potential clinical-biological prognostic factors - first cancer treatments: duration of treatment
Time frame: through study completion, an average of 6 months after patient inclusion
duration of treatment determined from the start and end dates
potential clinical-biological prognostic factors - first cancer treatments: cumulative dose received
Time frame: through study completion, an average of 6 months after patient inclusion
cumulative dose of each type of treatment received ( chemotherapy (Anthracyclines, Alkylating agents) and / or radiotherapy and/or Marrow autograft or allograft)
potential clinical-biological prognostic factors - secondary AML characteristics: date of diagnosis
Time frame: through study completion, an average of 6 months after patient inclusion
date of diagnosis
potential clinical-biological prognostic factors - secondary AML characteristics: median time of onset compared to the date of end of treatment for the 1st cancer
Time frame: through study completion, an average of 6 months after patient inclusion
median time of onset compared to the date of end of treatment for the 1st cancer
potential clinical-biological prognostic factors - secondary AML characteristics : hematological data assessed by morphology
Time frame: through study completion, an average of 6 months after patient inclusion
Leukocytes at diagnosis of secondary AML (G/L)
potential clinical-biological prognostic factors - secondary AML characteristics: cytogenetic data
Time frame: through study completion, an average of 6 months after patient inclusion
karyotype, exclusive and cumulative anomalies
potential clinical-biological prognostic factors - secondary AML characteristics: molecular data
Time frame: through study completion, an average of 6 months after patient inclusion
molecular data assessed by Next-Generation Sequencing panel
potential clinical-biological prognostic factors - secondary AML treatment: duration of treatment
Time frame: through study completion, an average of 6 months after patient inclusion
duration of treatment determined from the start and end dates
potential clinical-biological prognostic factors - secondary AML treatment: type of treatment
Time frame: through study completion, an average of 6 months after patient inclusion
chemotherapy received and bone marrow transplantation
potential clinical-biological prognostic factors - secondary AML treatment : response to treatment
Time frame: through study completion, an average of 6 months after patient inclusion
response measured by bone marrow assessment using morphology and minimal residual disease (MRD) assessment : no response, partial response, complete remission
potential clinical-biological prognostic factors - secondary AML treatment: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 6 months after patient inclusion
nature, incidence and severity of adverse events (AEs)
potential clinical-biological prognostic factors - Overall Survival (OS)
Time frame: at the end of the 2 years of the inclusion period
Evaluated as time from diagnostic of the second AML to death from any cause or date last seen for patients who are alive at the end of the trial
5 secondary outcomes
feasibility of setting up a French national database of secondary AMLs for children and adolescents - Number of cases included over the period
Time frame: at the end of the 2 years of the inclusion period
feasibility of setting up a French national database of secondary AMLs for children and adolescents - Missing Data
Time frame: at the end of the 2 years of the inclusion period
feasibility of setting up a French national database of secondary AMLs for children and adolescents - Centre participation rates
Time frame: at the end of the 2 years of the inclusion period
association of potential prognostic factors with event free survival and the occurrence of treatment-related toxicities- Recurrence of the disease
Time frame: at the end of the 2 years of the inclusion period
association of potential prognostic factors with event free survival and the occurrence of treatment-related toxicities- Treatment-related toxicities
Time frame: at the end of the 2 years of the inclusion period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myeloid, Acute, run by University Hospital, Bordeaux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane S DUCASSOU, MD PhD (05 57 82 04 38, stephane.ducassou@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
potential clinical-biological prognostic factors - patient characterics (time frame: through study completion, an average of 6 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.