Treatment of Children and Adolescents With Primary B-precursor Acute Lymphoblastic Leukemia With Combination Chemotherapy and Immunotherapy

Federal Research Institute of Pediatric Hematology, Oncology and Immunology4 sites in 1 country180 target enrollmentFebruary 1, 2020

ConditionsChildhood Acute Lymphoblastic Leukemia

InterventionsBlinatumomab

DrugsBlinatumomab

Overview

Phase: Not Applicable
Intervention: Blinatumomab
Conditions: Childhood Acute Lymphoblastic Leukemia
Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Enrollment: 180
Locations: 4
Primary Endpoint: Minimal residual disease level
Status: Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2020

End Date

December 2025

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Responsible Party

Sponsor

Eligibility Criteria

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:
•Age at diagnosis at 1 to 18 years.
•The start of induction therapy within a time interval of study recruitment phase.
•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).
•CD19 expression on tumor cells.
•Informed consent of the patient parents (guardians)

Exclusion Criteria

•Any non-compliance with the inclusion criteria.
•ALL is a second malignancy.
•There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
•The patient was treated before for a long time with cytotoxic drugs.
•Initial CNS (central nervous system) involvement (status CNSII or CNSIII).
•Initial leukocyte count ≥100×109/L (except for patients with significant translocations).
•Patients not achieved cytological remission after induction