Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma

August 27, 2024 updated by: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Locally manufactured second generation autologous CD19 CAR-T cells are used for immunotherapy. Protocol treatment includes lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one CAR-T cells intravenous infusion with tocilizumab premedication.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

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

Study Contact Backup

  • Name: Aleksandr Meleshko, PhD
  • Phone Number: +375296940023
  • Email: meleshko@tut.by

Study Locations

  • Belarus
    • Minsk Region
      • Minsk, Minsk Region, Belarus, 223053
        • Recruiting
        • Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
        • Contact:
          • Elena Lukoyko, MD
          • Phone Number: +37529 1643075

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

1 year to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: CD19 CAR-T cells immunotherapy
After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells
Biological: CD19 CAR-T-cells
One dose of CD19 CAR-T cells (1*10e6 CAR+ T-cells/kg) by intravenous infusion.
Drug: Tocilizumab
Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).
Other Names:
  • Actemra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 1 month
Adverse events will be graded according to the CTCAE v5.0
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 1 year
The proportion of patients with overall survival
1 year
Objective Response Rate (ORR) (CR+CRi+CRm)
Time Frame: 28 days after CAR-T cells infusion
The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), complete molecular remission (CRm).
28 days after CAR-T cells infusion
Events free survival (EFS)
Time Frame: 1 year
Time from CAR-T cells infusion to CR failure, relapse, or death.
1 year
Leukemia free survival (LFS)
Time Frame: 1 year
Time from achievement of CR/CRi/CRm to the time of relapse, death in remission, or last follow-up.
1 year

Collaborators and Investigators

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

Sponsor

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Investigators

  • Study Director: Olga Aleinikova, MD, Prof, Belarusian Research Center for Pediatric Oncology, Hematology 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)

October 26, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD19CAR-T_LL_children

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.

Clinical Trials on B-cell Acute Lymphoblastic Leukemia

Clinical Trials on CD19 CAR-T-cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe