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

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 res

Trial Details

NCT ID
NCT05029531
Phase
PHASE3
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • 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.
Locations (sample)
  • Moscow, Samory-Mashela,1, Russia|55.75204,37.61781

Key Eligibility 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…
  • Informed consent of the patient parents (guardians) to be treated in one of the clinics included in this study.

For full eligibility, visit ClinicalTrials.gov.

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