Childhood Acute Lymphoblastic Leukemia
Conditions
Keywords
Acute lymphoblastic leukemia, Children, Chemotherapy, Immunotherapy, Blinatumomab
Brief summary
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.
Interventions
DRUGBlinatumomab
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
Sponsors
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
This study included patients with B-cell precursor ALL (BCP-ALL) diagnosed or confirmed in one of the clinics participating in the study. Also following criteria should be considered at the diagnosis for each case: 1. Age at diagnosis at 1 to 18 years. 2. The start of induction therapy within a time interval of study recruitment phase. 3. The diagnosis of BCP-ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow in the reference laboratories of Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology (D. Rogachev NMRCPHOI). 4. CD19 expression on tumor cells. 5. Informed consent of the patient parents (guardians)
Exclusion criteria
1. Any non-compliance with the inclusion criteria. 2. ALL is a second malignancy. 3. There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.); 4. The patient was treated before for a long time with cytotoxic drugs. 5. Initial CNS (central nervous system) involvement (status CNSII or CNSIII). 6. Initial leukocyte count ≥100×109/L (except for patients with significant translocations). 7. Patients not achieved cytological remission after induction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal residual disease level | On the last day of the blinatumomab course, on average at 11 weeks of protocol |
| Event-free survival | 3 years after study start |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years after study start |
| Cumulative incidence of relapse | 3 years after study start |
| Remission death rate | 3 years after study start |
Countries
Russia
Contacts
Primary ContactAlexander I. Karachunskiy, Professor,MD
Backup ContactJulia V. Roumiantseva, MD, PhD
Outcome results
None listed