Menin inhibitors in pediatric relapsed or refractory acute leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a French multicenter retrospective observational study describing children treated with menin inhibitors for relapsed or refractory leukemia. Data from the SACHA database will cover patients from February 1, 2020, to July 31, 2026, focusing on safety, disease characteristics, and outcomes such as remission status and overall survival. The study will summarize treatment patterns, responses, and potential prognostic factors in a real-world setting. About 10 patients are expected to be included, reflecting rare molecular subgroups like KMT2A rearrangements, NUP98 rearrangements, or NPM1 mutations. No intervention is being assigned; investigators describe past treatment and outcomes from existing records.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients who received a Temporary Authorization for Use (ATU) but did not receive the treatment.

Where it's running

• Service de Pédiatrie 3 - Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg - France
  Strasbourg, France Recruiting

Study contacts

• Study coordinator: Catherine Paillard, MD, PhD
• Email: catherine.paillard@chru-strasbourg.fr
• Phone: 33 3 88 12 88 23

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.