THE PURPOSE OF THE STUDY is to optimize the therapy of patients with primary B-cell precursor acute lymphoblastic leukemia (BCP-ALL) by including monoclonal bispecific antibodies in post-induction treatment with simultaneous reduction of chemotherapy. QUESTIONS AND OBJECTIVES OF THE STUDY: * to determine the efficacy and feasibility of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL; * to determine the safety and toxicity of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL; * to determine the possibility of chemotherapy reducing when immunotherapy is included in the treatment regimen without loss of effectiveness; * to determine the possibility of reducing the maintenance therapy duration to 1 year when immunotherapy is included in the treatment regimen without loss of effectiveness.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Blinatumomab, intravenously, as continuous 24 hours infusion 1-7 days - 5 μg/m2/day, 8-28 day - 15 μg/m2/day 1 course after induction treatment
Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology
Moscow, Russia
RECRUITINGNational Medical Research Center of Oncology named after N.N. Blokhin
Moscow, Russia
RECRUITINGRussian Children's Clinic Hospital; Pirogov Russian National Research Medical University
Moscow, Russia
RECRUITINGAlmazov National Medical Research Centre
Saint Petersburg, Russia
RECRUITINGMinimal residual disease level
Time frame: On the last day of the blinatumomab course, on average at 11 weeks of protocol
Minimal residual disease level
Time frame: 6 months after starting maintenance therapy
Minimal residual disease level
Time frame: 1 year after starting maintenance therapy
Event-free survival
Time frame: 3 years after study start
Event-free survival
Time frame: 5 years after study start
Overall survival
Time frame: 3 years after study start
Overall survival
Time frame: 5 years after study start
Cumulative incidence of relapse
Time frame: 3 years after study start
Cumulative incidence of relapse
Time frame: 5 years after study start
Remission death rate
Time frame: 3 years after study start
Remission death rate
Time frame: 5 years after study start
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