CD19 T-CAR for Treatment of Children and Young Adults With r/r B-ALL

NCT03467256 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-02-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficiency of autologous CD19 CAR-T lymphocytes in a cohort of pediatric and young adult patients with relapsed /refractory B-lineage acute lymphoblastic leukemia

Conditions

Interventions

BIOLOGICAL

Chimeric Antigen Receptor T-Cell Therapy

anti-CD19 chimeric antigen receptor - transduced T-cell given IV

DRUG

Fludarabine

given IV

DRUG

Cyclophosphamide

given IV

DRUG

Tocilizumab

given IV

DRUG

Cytarabine

given IV

DRUG

Etoposide

given IV

DRUG

Dexamethasone

given IV

Sponsors & Collaborators

  • Federal Research Institute of Pediatric Hematology, Oncology and Immunology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2020-10-15
Completion
2025-10-15

Countries

  • Russia

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03467256 on ClinicalTrials.gov