Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CD19 CAR-T-cells, Tocilizumab.
- Who it may be relevant to
- Registry conditions: B-cell Acute Lymphoblastic Leukemia, Lymphoblastic B-Cell Lymphoma. Basic parameters: 1 year — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belarus
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults
Overview
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.
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.
Interventions
- 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).
Primary outcome measures
- Incidence of Treatment-Emergent Adverse Events [Time frame: 1 month]
Secondary outcome measures (4)
- Objective Response Rate (ORR) (CR+CRi+CRm) [Time frame: 28 days after CAR-T cells infusion]
- Overall survival (OS) [Time frame: 1 year]
- Events free survival (EFS) [Time frame: 1 year]
- Leukemia free survival (LFS) [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belarus · 1 center
- Belarussian Research Center for Pediatric Oncology, Hematology and Immunology — Minsk
Identifiers
NCT: NCT05333302 · CD19CAR-T_LL_children