Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot

January 22, 2021 updated by: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexander I. Karachunskiy, Professor,MD
  • Phone Number: +7-926-218-84-09
  • Email: info@mbstudy.net

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology
      • Moscow, Russian Federation
        • Recruiting
        • National Medical Research Center of Oncology named after N.N. Blokhin
      • Moscow, Russian Federation
        • Recruiting
        • Russian Children's Clinic Hospital; Pirogov Russian National Research Medical University
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Almazov National Medical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blinatumomab
Consolidation therapy with Blinatumomab administration
Drug: Blinatumomab

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Minimal residual disease level
Time Frame: On the last day of the blinatumomab course, on average at 11 weeks of protocol
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
6 months after starting maintenance therapy
Minimal residual disease level
Time Frame: 1 year after starting maintenance therapy
1 year after starting maintenance therapy
Event-free survival
Time Frame: 3 years after study start
3 years after study start
Event-free survival
Time Frame: 5 years after study start
5 years after study start

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years after study start
3 years after study start
Overall survival
Time Frame: 5 years after study start
5 years after study start
Cumulative incidence of relapse
Time Frame: 3 years after study start
3 years after study start
Cumulative incidence of relapse
Time Frame: 5 years after study start
5 years after study start
Remission death rate
Time Frame: 3 years after study start
3 years after study start
Remission death rate
Time Frame: 5 years after study start
5 years after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Investigators

  • Principal Investigator: Alexander I. Karachunskiy, Professor,MD, Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALL-MB 2019 Pilot

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe