Condition: Acute Lymphoblastic Leukemia, Pediatric · ALL, Infants · Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
The innovation of this protocol is the risk-adapted choice of therapy and the use of a combination of chemotherapy with immunotherapy and hematopoietic stem cell transplantation for patients with risk factors. Investigators have proposed a two-stage stratification into risk groups: Initially: * Standard risk: patients with no rearrangement of the KMT2A gene. * Intermediate risk: patients with rearrangement of the KMT2A gene without damage to the central nervous system. * High risk: patients with rearrangement of the KMT2A gene with lesions of the central nervous system. According to the results of induction therapy: * The high-risk group includes patients from the standard risk group with an MRD level of more than 0.1% after the induction course and from the intermediate risk group with MRD-positive (PCR) after HR1 block. * The allocation of children in the first year of life without the rearranged KMT2A gene into a separate group seems to be logical, since the prognosis in this group is better than in children with the rearranged KMT2A gene. In this protocol, non-intensive therapy with consolidations and maintenance therapy remains for those who achieve a low MRD level (less than 0.1%) after a course of induction. The rest of the patients move into a high-risk group: they receive blinatumomab and HSCT. * The concept of therapy for patients at intermediate risk is based on the rate at which MRD-negativity is achieved: standard consolidation and maintenance therapy for tho…
This description comes directly from the study's public registry record.
Natalya f Myakova, PD · +79035083576 · Natalya.Myakova@fccho-moscow.ru
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| Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology | Moscow, Samory-Mashela,1, Russia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05029531