NCT05333302

Brief Summary

The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2020

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

4.1 years

First QC Date

April 12, 2022

Last Update Submit

August 27, 2024

Conditions

B-cell Acute Lymphoblastic LeukemiaLymphoblastic B-Cell Lymphoma

Keywords

immunotherapyCAR-T cellsCD19

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    Adverse events will be graded according to the CTCAE v5.0

    1 month

Secondary Outcomes (4)

  • Objective Response Rate (ORR) (CR+CRi+CRm)

    28 days after CAR-T cells infusion

  • Overall survival (OS)

    1 year

  • Events free survival (EFS)

    1 year

  • Leukemia free survival (LFS)

    1 year

Study Arms (1)

CD19 CAR-T cells immunotherapy

EXPERIMENTAL

After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells

Biological: CD19 CAR-T-cellsDrug: Tocilizumab

Interventions

CD19 CAR-T-cellsBIOLOGICAL

One dose of CD19 CAR-T cells (1\*10e6 CAR+ T-cells/kg) by intravenous infusion.

CD19 CAR-T cells immunotherapy
TocilizumabDRUG

Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).

Also known as: Actemra
CD19 CAR-T cells immunotherapy

Eligibility Criteria

Age1 Year - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • CD19+ relapsed or refractory lymphoblastic leukemia/lymphoma;
  • Karnofsky or Lansky performance scale greater or equal to 70;
  • T-cells count in peripheral blood \>150 cells/µL;
  • Written informed consent.

You may not qualify if:

  • primary immunodeficiencies or genetic syndromes;
  • neurologic diseases;
  • autoimmune diseases or polyallergie;
  • transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion;
  • GvHD grade 2-4;
  • uncontrolled systemic infection;
  • hypoxia (Sp02\<90%)
  • severe hepatic dysfunction: ALT or AST \>=3x upper limit of normal for age;
  • renal dysfunction: serum creatinine level \>=3x upper limit of normal for age;
  • positive serology for human immunodeficiency virus (HIV), active hepatite C or B;
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Minsk, Minsk Oblast, 223053, Belarus

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Olga Aleinikova, MD, Prof

    Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

    STUDY DIRECTOR

Central Study Contacts

Elena Lukoyko, MD

CONTACT

+375291643075lenalukojko@gmail.com

Aleksandr Meleshko, PhD

CONTACT

+375296940023meleshko@tut.by

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 18, 2022

Study Start

October 26, 2020

Primary Completion

December 1, 2024

Study Completion

June 1, 2025

Last Updated

August 28, 2024

Record last verified: 2024-08

Locations

BE(1)