Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    180
  • sponsor
    Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Updated on 31 January 2021

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.

Details
Condition childhood ALL, Lymphocytic Leukemia, Acute, Lymphocytic Leukemia, Acute
Treatment Blinatumomab
Clinical Study IdentifierNCT04723342
SponsorFederal Research Institute of Pediatric Hematology, Oncology and Immunology
Last Modified on31 January 2021

Eligibility

Yes No Not Sure

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 100109/L (except for patients with significant translocations)
Patients not achieved cytological remission after induction
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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