An observational study in Acute Leukemia, Relapsed or Refractory Pediatric Leukemia and KMT2A-rearranged, NUP98-rearranged, or NPM1-mutated Leukemia, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by University Hospital, Strasbourg, France · Observational
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.
4,352 studies on the registry are indexed under Recurrence; 1,003 are open to participants now.
This study's planned enrollment of 10 is below the median of 200 across 707 observational studies indexed under Recurrence.
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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.
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Exclusion Criteria:
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.
Time frame: From February 1, 2020, to July 31, 2026.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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