B-cell Acute Lymphoblastic Leukemia, Lymphoblastic B-Cell Lymphoma
Conditions
Keywords
immunotherapy, CAR-T cells, CD19
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.
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
BIOLOGICALCD19 CAR-T-cells
One dose of CD19 CAR-T cells (1\*10e6 CAR+ T-cells/kg) by intravenous infusion.
DRUGTocilizumab
Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).
Sponsors
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 30 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 1 month | Adverse events will be graded according to the CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) (CR+CRi+CRm) | 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). |
| Overall survival (OS) | 1 year | The proportion of patients with overall survival |
| Events free survival (EFS) | 1 year | Time from CAR-T cells infusion to CR failure, relapse, or death. |
| Leukemia free survival (LFS) | 1 year | Time from achievement of CR/CRi/CRm to the time of relapse, death in remission, or last follow-up. |
Countries
Belarus
Contacts
Primary ContactElena Lukoyko, MD
Backup ContactAleksandr Meleshko, PhD
Outcome results
None listed