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Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)

RecruitingPhase 3Ages 1 Day - 365 DaysAllFederal Research Institute of Pediatric Hematolog…
NCT05029531 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age at diagnosis at 1 to 365 days of life. * The start of induction therapy within a time interval of study recruitment phase. * The diagnosis of ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow (see "Diagnostics"). Patients with B-cell (Burkitt) ALL are excluded. * Informed consent of the patient parents (guardians) to be treated in one of the clinics included in this study. Exclusion Criteria: * The disease is a relapse of previously misdiagnosed and, therefore, inadequately treated ALL; * There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.); * There is a lack of important data needed for the exact adherence to the cytostatic therapy according to a specific chemotherapy protocol (differential diagnosis of ALL-AML (acute myeloid leukemia) is not possible, stratification according to therapeutic group is not possible); * The patient was treated before for a long time with cytotoxic drugs; * There were treatment deviations not covered by the protocol and/or not due to side effects of treatment and/or complications of the disease
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What it tests

  • 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.
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Where

1 site
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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