Acute LeukemiaMENIN-PEDNCT07898436
Menin Inhibitors in Pediatric Relapsed or Refractory Acute Leukemia
An observational study of Acute Leukemia and Relapsed or Refractory Pediatric Leukemia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Acute leukemia is the most common childhood cancer. Despite advances in targeted therapies and immunotherapies, treatment remains challenging for children with relapsed or refractory acute leukemia, particularly those with KMT2A rearrangements, NPM1 mutations, or NUP98 rearrangements. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Acute Leukemia, Relapsed or Refractory Pediatric Leukemia, KMT2A-rearranged, NUP98-rearranged, or NPM1-mutated Leukemia
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2026to 8 Mar 2027
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children who were younger than 18 years at acute leukemia diagnosis and who received menin inhibitor treatment for relapsed or refractory acute leukemia associated with a KMT2A or NUP98 rearrangement or an NPM1 mutation. Patients will be identified through the SACHA database. Approximately 10 patient records from the period February 1, 2020, to July 31, 2026, are expected to be analyzed.
Who may be able to join
- Patients with relapsed or refractory acute leukemia eligible for menin inhibitor treatment because of a KMT2A or NUP98 rearrangement or an NPM1 mutation.
- Patients who received menin inhibitor treatment under a Temporary Authorization for Use (ATU).
- Patients younger than 18 years at the time of acute leukemia diagnosis.
- Patients who have not objected to the reuse of their data for scientific research.
- Patients whose holders of parental authority have already provided authorization for the reuse of the child's data for scientific research.
Who cannot join
- Patients who received a Temporary Authorization for Use (ATU) but did not receive the treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Pédiatrie 3 - Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg - France
Strasbourg, 67091
Catherine Paillard, MD, PhD, 33 3 88 12 88 23, catherine.paillard@chru-strasbourg.fr
Catherine Paillard, MD, PhD
About this study
Official title: Management of Relapsed or Refractory Acute Leukemia With Menin Inhibitors in Children: A French National Retrospective Study
Acute leukemia is the most common childhood cancer. Despite advances in targeted therapies and immunotherapies, treatment remains challenging for children with relapsed or refractory acute leukemia, particularly those with KMT2A rearrangements, NPM1 mutations, or NUP98 rearrangements. Menin inhibitors have shown promising antileukemic activity in these molecular subgroups.
This French national, multicenter, retrospective observational study will describe the pediatric population treated with menin inhibitors for relapsed or refractory acute leukemia. Clinical and biological data will be collected from the SACHA database for patients treated between February 1, 2020, and July 31, 2026. Approximately 10 patients are expected to be included. The study will describe patient and disease characteristics, treatment administration, safety, and efficacy, including remission status, minimal residual disease, relapse, and overall survival.
- Conditions
- Acute Leukemia, Relapsed or Refractory Pediatric Leukemia, KMT2A-rearranged, NUP98-rearranged, or NPM1-mutated Leukemia, Menin Inhibitor Treatment
- Keywords
- Menin inhibitors, Pediatric acute leukemia, Relapsed or refractory leukemia
- Medical subject headings
- Recurrence, Leukemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and biological characteristics of pediatric patients treated with menin inhibitors for relapsed or refractory acute leukemia
Descriptive assessment of the patient population, including clinical symptoms and biological characteristics at diagnosis, time to refractory disease or relapse, previous treatment regimens, and minimal residual disease monitoring during leukemia management.
Measured: From February 1, 2020, to July 31, 2026.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start8 Sep 2026
- Primary completion8 Jan 2027 (estimated)
- Study completion8 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898436
- Sponsor's protocol ID
- RC26_0311
- Acronym
- MENIN-PED
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Relapsed or Refractory Acute Leukemia With Menin Inhibitors in Children: A French National Retrospective Study
- ClinicalTrials.gov ID
- NCT07898436
- Acronym / sponsor ID
- MENIN-PED / RC26_0311
- Conditions
- Acute Leukemia, Relapsed or Refractory Pediatric Leukemia, KMT2A-rearranged, NUP98-rearranged, or NPM1-mutated Leukemia, Menin Inhibitor Treatment
- Keywords
- Menin inhibitors, Pediatric acute leukemia, Relapsed or refractory leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 8 Jan 2027 (estimated)
- Study completion
- 8 Mar 2027 (estimated)
- First posted
- 27 Oct 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.
Acute leukemia is the most common childhood cancer. Despite advances in targeted therapies and immunotherapies, treatment remains challenging for children with relapsed or refractory acute leukemia, particularly those with KMT2A rearrangements, NPM1 mutations, or NUP98 rearrangements. Menin inhibitors have shown promising antileukemic activity in these molecular subgroups.
This French national, multicenter, retrospective observational study will describe the pediatric population treated with menin inhibitors for relapsed or refractory acute leukemia. Clinical and biological data will be collected from the SACHA database for patients treated between February 1, 2020, and July 31, 2026. Approximately 10 patients are expected to be included. The study will describe patient and disease characteristics, treatment administration, safety, and efficacy, including remission status, minimal residual disease, relapse, and overall survival.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children who were younger than 18 years at acute leukemia diagnosis and who received menin inhibitor treatment for relapsed or refractory acute leukemia associated with a KMT2A or NUP98 rearrangement or an NPM1 mutation. Patients will be identified through the SACHA database. Approximately 10 patient records from the period February 1, 2020, to July 31, 2026, are expected to be analyzed.
Key inclusion criteria (5 listed)
- Patients with relapsed or refractory acute leukemia eligible for menin inhibitor treatment because of a KMT2A or NUP98 rearrangement or an NPM1 mutation.
- Patients who received menin inhibitor treatment under a Temporary Authorization for Use (ATU).
- Patients younger than 18 years at the time of acute leukemia diagnosis.
- Patients who have not objected to the reuse of their data for scientific research.
- Patients whose holders of parental authority have already provided authorization for the reuse of the child's data for scientific research.
Key exclusion criteria (1 listed)
- Patients who received a Temporary Authorization for Use (ATU) but did not receive the treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical and biological characteristics of pediatric patients treated with menin inhibitors for relapsed or refractory acute leukemia
Time frame: From February 1, 2020, to July 31, 2026.
Descriptive assessment of the patient population, including clinical symptoms and biological characteristics at diagnosis, time to refractory disease or relapse, previous treatment regimens, and minimal residual disease monitoring during leukemia management.
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 27 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia and Relapsed or Refractory Pediatric Leukemia, run by University Hospital, Strasbourg, France at 1 site 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 5 inclusion and 1 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Catherine Paillard, MD, PhD (33 3 88 12 88 23, catherine.paillard@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and biological characteristics of pediatric patients treated with menin inhibitors for relapsed or refractory acute leukemia (time frame: From February 1, 2020, to July 31, 2026.). 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 27 Oct 2026.