Acute Lymphoblastic Leukemia ALLCIRCALLNCT07483476
Study of Cell-free DNA in Children and Adolescents With Acute Lymphoblastic Leukemia
An observational study of Acute Lymphoblastic Leukemia ALL, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Minimal residual disease (MRD) monitoring is a key prognostic factor in pediatric acute lymphoblastic leukemia (ALL). Currently, MRD assessment relies mainly on cellular DNA obtained from bone marrow aspirates. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoblastic Leukemia ALL
- What is being tested?
- Biological sample collection
- How many people
- 205 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Apr 2026to 24 Apr 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult
Study population: Study population Children and adolescents with newly diagnosed acute lymphoblastic leukemia treated in participating pediatric hematology centers, as well as healthy pediatric siblings undergoing HLA typing.
Who may be able to join
- ALL population
- Age < 18 years
- Newly diagnosed B-cell or T-cell acute lymphoblastic leukemia
- Absence of BCR::ABL1 rearrangement
- For infants (<12 months), absence of KMT2A rearrangement
- Inclusion before initiation of corticosteroid therapy or chemotherapy
Show all 13Show fewer
- Written informed consent from legal guardians
- Affiliation to a national health insurance system Control population
- Age < 18 years
- Undergoing blood sampling for HLA typing in the context of bone marrow donor evaluation
- Sibling of a patient with leukemia
- Written informed consent from legal guardians
- Affiliation to a national health insurance system
Who cannot join
- Pregnant or breastfeeding patients
- Patients not affiliated with a health insurance system
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Armand Trousseau
Paris
Arnaud Petit, 0144736346 ext. +33, arnaud.petit@aphp.fr
arnaud.petit@aphp.fr
- Recruiting
Hôpital Robert Debré
Paris
Marion Strullu, 0140035388 ext. +33, marion.strullu@aphp.fr
About this study
Official title: Etude de l'ADN Libre Circulant Dans Les leucémies Aigues Lymphoblastiques de l'Enfant et de l'Adolescent
Minimal residual disease (MRD) monitoring is a key prognostic factor in pediatric acute lymphoblastic leukemia (ALL). Currently, MRD assessment relies mainly on cellular DNA obtained from bone marrow aspirates. Although highly informative, this approach has limitations, including the need for invasive procedures and the fact that it reflects only the bone marrow compartment.
Tumor cells release fragments of genomic DNA into the bloodstream, known as circulating cell-free DNA (cfDNA). In solid tumors, cfDNA analysis has emerged as a valuable non-invasive biomarker for disease monitoring and treatment response. Recent studies have shown that cfDNA is detectable in pediatric ALL.
Read more
This study aims to investigate whether plasma cfDNA analysis could represent an alternative or complementary approach to bone marrow-based MRD assessment. cfDNA may better reflect the global tumor burden across the entire body and allow more frequent longitudinal monitoring during treatment.
The primary objective is to assess the correlation between MRD measured in plasma cfDNA and MRD measured in bone marrow cellular DNA at two key timepoints of treatment: the end of induction (Day 29) and the end of consolidation (Day 71-78).
Secondary objectives include evaluating the correlation between peripheral blood cellular DNA and bone marrow MRD, describing clonal evolution using cfDNA throughout treatment and follow-up, exploring the concordance of genomic alterations detected in cfDNA and other biological compartments, assessing the prognostic value of cfDNA MRD for relapse risk and event-free survival, and characterizing cfDNA fragmentome and methylome signatures in patients compared with healthy controls.
The study will include children and adolescents with newly diagnosed ALL treated at two AP-HP pediatric hematology centers, as well as a control cohort of healthy children undergoing HLA typing for sibling stem cell transplant.
- Conditions
- Acute Lymphoblastic Leukemia ALL
- Being tested
- Biological sample collection
- Keywords
- Pediatric acute lymphoblastic leukemia, Minimal residual disease, Cell-free DNA, Liquid biopsy, Fragmentomics, Methylome, Clonal evolution
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collectionOther
Additional peripheral blood samples will be collected during treatment and follow-up for cell-free DNA analysis. Residual samples from bone marrow and cerebrospinal fluid collected as part of standard clinical care will also be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| ALL patients | Children and adolescents (<18 years) with newly diagnosed B-cell or T-cell acute lymphoblastic leukemia without BCR::ABL1 rearrangement (and without KMT2A rearrangement in infants), included before initiation of steroid therapy or chemotherapy. Receives: Other: Biological sample collection | |
| Healthy control participants | Children and adolescents (<18 years) undergoing blood sampling for HLA typing for a sibling with leukemia. Receives: Other: Biological sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between plasma cfDNA MRD and bone marrow MRD
Pearson correlation coefficient between minimal residual disease (MRD) measured in plasma circulating cell-free DNA and MRD measured in bone marrow cellular DNA. Analyses will be performed according to the type of molecular target used for MRD detection (IG/TCR rearrangements, genomic breakpoints, or pathogenic variants).
End of induction (Day 29) and end of consolidation (Day 71-78)
Measured: Up to day 78 (end of consolidation)
Secondary outcomes (13)
Correlation between peripheral blood cellular DNA MRD and bone marrow MRD
Pearson correlation coefficient between MRD measured in peripheral blood cellular DNA and MRD measured in bone marrow cellular DNA.
Measured: At day 29
Correlation between peripheral blood cellular DNA MRD and bone marrow MRD
Pearson correlation coefficient between MRD measured in peripheral blood cellular DNA and MRD measured in bone marrow cellular DNA.
At day 71 to 78
Measured: At day 78
Clonal evolution detected in cell-free DNA
Mutation profiles of cfDNA across multiple timepoints during treatment and follow-up
Measured: At day 1
Clonal evolution detected in cell-free DNA
Mutation profiles of cfDNA across multiple timepoints during treatment and follow-up
Measured: At day 4
Clonal evolution detected in cell-free DNA
Mutation profiles of cfDNA across multiple timepoints during treatment and follow-up
Measured: At day 8
Clonal evolution detected in cell-free DNA
Mutation profiles of cfDNA across multiple timepoints during treatment and follow-up
Measured: At day 15
Clonal evolution detected in cell-free DNA
Mutation profiles of cfDNA across multiple timepoints during treatment and follow-up
Measured: At day 29
Clonal evolution detected in cell-free DNA
Mutation profiles of cfDNA across multiple timepoints during treatment and follow-up At day 71 to 78
Measured: At day 78
Clonal evolution detected in cell-free DNA
Mutation profiles of cfDNA across multiple timepoints during treatment and follow-up
Measured: At end of maintenance
Clonal evolution detected in cell-free DNA
Mutation profiles of cfDNA across multiple timepoints during treatment and follow-up
Measured: 3 years after remission
Concordance of genomic alterations between cfDNA and other biological compartments
Qualitative and quantitative comparison of genomic alterations detected at diagnosis in cfDNA and in other sample types (bone marrow, cerebrospinal fluid, and other tissues if available)
Measured: At diagnosis
Prognostic value of cfDNA MRD
Association between cfDNA MRD levels and relapse-free survival and event-free survival
Measured: Up to 5 years of follow-up
Fragmentome and methylome profiles of circulating DNA
Characterization and comparison of cfDNA fragment size patterns and methylation signatures between patients and healthy controls at diagnosis and during treatment.
At baseline and during treatment
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start24 Apr 2026
- Primary completion24 Jul 2029 (estimated)
- Study completion24 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia ALLStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483476
- Sponsor's protocol ID
- APHP251017
- Other IDs
- 2025-A01461-48
- Acronym
- CIRCALL
- Status last verified
- Aug 2026
- First submitted
- 16 Mar 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de l'ADN Libre Circulant Dans Les leucémies Aigues Lymphoblastiques de l'Enfant et de l'Adolescent
- ClinicalTrials.gov ID
- NCT07483476
- Acronym / sponsor ID
- CIRCALL / APHP251017
- Conditions
- Acute Lymphoblastic Leukemia ALL
- Keywords
- Pediatric acute lymphoblastic leukemia, Minimal residual disease, Cell-free DNA, Liquid biopsy, Fragmentomics, Methylome, Clonal evolution
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 24 Jul 2029 (estimated)
- Study completion
- 24 Apr 2034 (estimated)
- First posted
- 19 Mar 2026 (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.
Minimal residual disease (MRD) monitoring is a key prognostic factor in pediatric acute lymphoblastic leukemia (ALL). Currently, MRD assessment relies mainly on cellular DNA obtained from bone marrow aspirates. Although highly informative, this approach has limitations, including the need for invasive procedures and the fact that it reflects only the bone marrow compartment.
Tumor cells release fragments of genomic DNA into the bloodstream, known as circulating cell-free DNA (cfDNA). In solid tumors, cfDNA analysis has emerged as a valuable non-invasive biomarker for disease monitoring and treatment response. Recent studies have shown that cfDNA is detectable in pediatric ALL.
This study aims to investigate whether plasma cfDNA analysis could represent an alternative or complementary approach to bone marrow-based MRD assessment. cfDNA may better reflect the global tumor burden across the entire body and allow more frequent longitudinal monitoring during treatment.
The primary objective is to assess the correlation between MRD measured in plasma cfDNA and MRD measured in bone marrow cellular DNA at two key timepoints of treatment: the end of induction (Day 29) and the end of consolidation (Day 71-78).
Secondary objectives include evaluating the correlation between peripheral blood cellular DNA and bone marrow MRD, describing clonal evolution using cfDNA throughout treatment and follow-up, exploring the concordance of genomic alterations detected in cfDNA and other biological compartments, assessing the prognostic value of cfDNA MRD for relapse risk and event-free survival, and characterizing cfDNA fragmentome and methylome signatures in patients compared with healthy controls.
The study will include children and adolescents with newly diagnosed ALL treated at two AP-HP pediatric hematology centers, as well as a control cohort of healthy children undergoing HLA typing for sibling stem cell transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALL patients | – | Other: Biological sample collectionChildren and adolescents (<18 years) with newly diagnosed B-cell or T-cell acute lymphoblastic leukemia without BCR::ABL1 rearrangement (and without KMT2A rearrangement in infants), included before initiation of steroid therapy or chemotherapy. |
| Healthy control participants | – | Other: Biological sample collectionChildren and adolescents (<18 years) undergoing blood sampling for HLA typing for a sibling with leukemia. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study population Children and adolescents with newly diagnosed acute lymphoblastic leukemia treated in participating pediatric hematology centers, as well as healthy pediatric siblings undergoing HLA typing.
Key inclusion criteria (13 listed)
- ALL population
- Age < 18 years
- Newly diagnosed B-cell or T-cell acute lymphoblastic leukemia
- Absence of BCR::ABL1 rearrangement
- For infants (<12 months), absence of KMT2A rearrangement
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding patients
- Patients not affiliated with a health insurance system
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 |
|---|---|---|
| Biological sample collectionAdditional peripheral blood samples will be collected during treatment and follow-up for cell-free DNA analysis. Residual samples from bone marrow and cerebrospinal fluid collected as part of standard clinical care will also be analyzed. | Other | ALL patients, Healthy control participants |
Primary outcome
Correlation between plasma cfDNA MRD and bone marrow MRD
Time frame: Up to day 78 (end of consolidation)
Pearson correlation coefficient between minimal residual disease (MRD) measured in plasma circulating cell-free DNA and MRD measured in bone marrow cellular DNA. Analyses will be performed according to the type of molecular target used for MRD detection (IG/TCR rearrangements, genomic breakpoints, or pathogenic variants). End of induction (Day 29) and end of consolidation (Day 71-78)
13 secondary outcomes
Correlation between peripheral blood cellular DNA MRD and bone marrow MRD
Time frame: At day 29
Correlation between peripheral blood cellular DNA MRD and bone marrow MRD
Time frame: At day 78
Clonal evolution detected in cell-free DNA
Time frame: At day 1
Clonal evolution detected in cell-free DNA
Time frame: At day 4
Clonal evolution detected in cell-free DNA
Time frame: At day 8
Clonal evolution detected in cell-free DNA
Time frame: At day 15
Clonal evolution detected in cell-free DNA
Time frame: At day 29
Clonal evolution detected in cell-free DNA
Time frame: At day 78
Clonal evolution detected in cell-free DNA
Time frame: At end of maintenance
Clonal evolution detected in cell-free DNA
Time frame: 3 years after remission
Concordance of genomic alterations between cfDNA and other biological compartments
Time frame: At diagnosis
Prognostic value of cfDNA MRD
Time frame: Up to 5 years of follow-up
Fragmentome and methylome profiles of circulating DNA
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia ALL, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 13 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion Strullu, MD PhD (+330140035388 ext. +33, marion.strullu@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between plasma cfDNA MRD and bone marrow MRD (time frame: Up to day 78 (end of consolidation)). 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 26 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.