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Of the 139 patients enrolled in the MLL\u2010Baby study, 100 (71.9%) carried different types of rearranged <jats:italic>KMT2A<\/jats:italic> (<jats:italic>KMT2A<\/jats:italic>\u2010r), while the remaining 39 infants (28.1%) had <jats:italic>KMT2A<\/jats:italic>\u2010g. <jats:italic>KMT2A<\/jats:italic>\u2010g patients were generally older (77% older than 6\u00a0months), less likely to have a very high white blood cell count (greater than 100\u00a0\u00d7\u00a010<jats:sup>9<\/jats:sup>\/L), less likely to be central nervous system (CNS)\u2010positive, and more likely to be CD10\u2010positive. The 6\u2010year event\u2010free survival and overall survival rates for all 39 patients were 0.74 (standard error [SE] 0.07) and 0.80 (SE 0.07), respectively. Relapse was the most common adverse event (<jats:italic>n<\/jats:italic>\u00a0=\u00a05), with a cumulative incidence of relapse (CIR) of 0.13 (SE 0.06), while the incidence of a second malignancy (<jats:italic>n<\/jats:italic>\u00a0=\u00a01) and death in remission (<jats:italic>n<\/jats:italic>\u00a0=\u00a03) was 0.03 (SE 0.04) and 0.08 (SE 0.04), respectively. None of the initial parameters, including genetics and the presence of recently described fusions of <jats:italic>NUTM1<\/jats:italic> and <jats:italic>PAX5<\/jats:italic> genes, was able to distinguish patients with different outcomes. Only rapidity of response, measured as minimal residual disease (MRD) by flow cytometry, showed a statistically significant impact. Moderate\u2010intensity therapy, as used in the MLL\u2010Baby protocol in infants with <jats:italic>KMT2A<\/jats:italic>\u2010g BCP\u2010ALL, yields results comparable to other infant studies. Patients with a slow multicolor flow cytometry (MFC)\u2010MRD response should be subjected to advanced therapies, such as targeted or immunotherapies.<\/jats:p>","DOI":"10.1002\/pbc.30204","type":"journal-article","created":{"date-parts":[[2023,1,30]],"date-time":"2023-01-30T11:01:18Z","timestamp":1675076478000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Genetic characteristics and treatment outcome in infants with <i>KMT2A<\/i> germline B\u2010cell precursor acute lymphoblastic leukemia: Results of MLL\u2010Baby protocol"],"prefix":"10.1002","volume":"70","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0889-6986","authenticated-orcid":false,"given":"Alexander","family":"Popov","sequence":"first","affiliation":[{"name":"National Research and Clinical Centre for Pediatric Hematology, Oncology and Immunology  Moscow Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9881-6221","authenticated-orcid":false,"given":"Grigory","family":"Tsaur","sequence":"additional","affiliation":[{"name":"Regional Children's Hospital  Ekaterinburg Russian Federation"},{"name":"Ural State Medical University  Ekaterinburg Russian Federation"},{"name":"Research Institute of Medical Cell Technologies  Ekaterinburg Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhan","family":"Permikin","sequence":"additional","affiliation":[{"name":"Regional Children's Hospital  Ekaterinburg Russian Federation"},{"name":"Ural State Medical University  Ekaterinburg Russian Federation"},{"name":"Research Institute of Medical Cell Technologies  Ekaterinburg Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guenter","family":"Henze","sequence":"additional","affiliation":[{"name":"Department of Pediatric Oncology Hematology Charit\u00e9 \u2010 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatiana","family":"Verzhbitskaya","sequence":"additional","affiliation":[{"name":"Regional Children's Hospital  Ekaterinburg Russian Federation"},{"name":"Research Institute of Medical Cell Technologies  Ekaterinburg Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Plekhanova","sequence":"additional","affiliation":[{"name":"Regional Children's Hospital  Ekaterinburg Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ekaterina","family":"Nokhrina","sequence":"additional","affiliation":[{"name":"Regional Children's Hospital  Ekaterinburg Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alena","family":"Valochnik","sequence":"additional","affiliation":[{"name":"Belarussian Research Centre for Pediatric Oncology, Hematology and Immunology  Minsk Belarus"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petr","family":"Sibiryakov","sequence":"additional","affiliation":[{"name":"Regional Children's Hospital  Ekaterinburg Russian Federation"},{"name":"Research Institute of Medical Cell Technologies  Ekaterinburg Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9634-5828","authenticated-orcid":false,"given":"Elena","family":"Zerkalenkova","sequence":"additional","affiliation":[{"name":"National Research and Clinical Centre for Pediatric Hematology, Oncology and Immunology  Moscow Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yulia","family":"Olshanskaya","sequence":"additional","affiliation":[{"name":"National Research and Clinical Centre for Pediatric Hematology, Oncology and Immunology  Moscow Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatiana","family":"Gindina","sequence":"additional","affiliation":[{"name":"R.M. 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