NCT04723342

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

January 19, 2021

Last Update Submit

January 22, 2021

Conditions

Childhood Acute Lymphoblastic Leukemia

Keywords

Acute lymphoblastic leukemiaChildrenChemotherapyImmunotherapyBlinatumomab

Outcome Measures

Primary Outcomes (5)

  • Minimal residual disease level

    On the last day of the blinatumomab course, on average at 11 weeks of protocol

  • Minimal residual disease level

    6 months after starting maintenance therapy

  • Minimal residual disease level

    1 year after starting maintenance therapy

  • Event-free survival

    3 years after study start

  • Event-free survival

    5 years after study start

Secondary Outcomes (6)

  • Overall survival

    3 years after study start

  • Overall survival

    5 years after study start

  • Cumulative incidence of relapse

    3 years after study start

  • Cumulative incidence of relapse

    5 years after study start

  • Remission death rate

    3 years after study start

  • +1 more secondary outcomes

Study Arms (1)

Blinatumomab

EXPERIMENTAL

Consolidation therapy with Blinatumomab administration

Drug: Blinatumomab

Interventions

BlinatumomabDRUG

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

Blinatumomab

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology

Moscow, Russia

RECRUITING

National Medical Research Center of Oncology named after N.N. Blokhin

Moscow, Russia

RECRUITING

Russian Children's Clinic Hospital; Pirogov Russian National Research Medical University

Moscow, Russia

RECRUITING

Almazov National Medical Research Centre

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Alexander I. Karachunskiy, Professor,MD

    Federal Research Institute of Pediatric Hematology, Oncology and Immunology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander I. Karachunskiy, Professor,MD

CONTACT

+7-926-218-84-09info@mbstudy.net

Julia V. Roumiantseva, MD, PhD

CONTACT

+7-903-730-39-78j.roumiantseva@mbstudy.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 25, 2021

Study Start

February 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2025

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations

RU(4)