METHOD FOR THE TREATMENT OF ACUTE LYMPHOBLASTIC LEUKEMIA FROM PROGENITOR B-CELLS WITH REARRANGEMENTS IN THE KMT2A GENE IN CHILDREN OF THE FIRST YEAR OF LIFE Russian patent published in 2023 - IPC A61M5/00 A61K31/573 A61K31/435 A61K31/704 A61K31/7064 A61K31/196 A61K39/395 A61K35/28 A61P35/02 

FIELD: medicine.

SUBSTANCE: invention relates to pediatric oncology-hematology, and can be used in the treatment of children of the first year of life diagnosed with acute lymphoblastic leukemia from progenitor B-cells with mutations in the KMT2A gene. The method includes, at the first stage, from the 1st to the 36th days inclusive, induction therapy, including intravenous administration of the glucocorticosteroid drug dexamethasone at a daily dose of 6 mg/m² dose of 1.5 mg/m², two injections of the anthracycline antitumor antibiotic daunorubicin at a single dose of 45 mg/m² on the 8th and 22nd days, the preparation of pegylated L-asparaginase at a dose of 1,000 IU/m² per day once from 5 1st to 7th days, also 6 weekly, on the same day, intrathecal injections of the antimetabolite methotrexate at a dose of 6 mg, the alkylating drug cytosar at a dose of 20 mg and dexamethasone at a dose of 1 mg. At the second stage, within one day, high-dose therapy is carried out in the form of an HR-1 block as part of intravenous administration of dexamethasone at a dose of 20 mg/m² in two injections, methotrexate at a dose of 5,000 mg/m², vincristine at a dose of 1.5 mg/m², cytosar at a dose of 2,000 mg/m², pegylated L-asparaginase at a dose of 1,000 IU/m², methotrexate at a dose of 6 mg, cytarabine at a dose of 20 mg and dexamethasone at a dose of 1 mg are administered intrathecally to patients. At the third stage, during the first 7 days, continuous intravenous antitumor immunotherapy is carried out with the preparation of monoclonal bispecific antibodies blinatumomab at a dose of 5 μg/m² per day, followed, from the 8th to the 28th day, by continuous intravenous infusion of blinatumomab at a dose of 15 μg/m². Doses of all chemotherapy drugs are adjusted depending on the patient's age in months: 0–6 months — 2/3 of a dose, 6–11 months — 3/4 of a dose, 12 months — full dose, calculated per m². At the final, fourth stage, transplantation of hematopoietic stem cells is performed.

EFFECT: use of the invention makes it possible to achieve rapid and complete clearance of the chimeric transcript and low levels of minimal residual disease, followed by consolidation of the obtained therapeutic result.

1 cl, 1 ex