Back to resultsPilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
Primary Purpose
B-cell Acute Lymphoblastic Leukemia, Lymphoblastic B-Cell Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
CD19 CAR-T-cells
Tocilizumab
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia focused on measuring immunotherapy, CAR-T cells, CD19
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.
Sites / Locations
- Belarussian Research Center for Pediatric Oncology, Hematology and ImmunologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD19 CAR-T cells immunotherapy
Arm Description
After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
Adverse events will be graded according to the CTCAE v5.0
Secondary Outcome Measures
Objective Response Rate (ORR) (CR+CRi+CRm)
The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), complete molecular remission (CRm).
Overall survival (OS)
The proportion of patients with overall survival
Events free survival (EFS)
Time from CAR-T cells infusion to CR failure, relapse, or death.
Leukemia free survival (LFS)
Time from achievement of CR/CRi/CRm to the time of relapse, death in remission, or last follow-up.
Full Information
NCT ID
NCT05333302
First Posted
April 12, 2022
Last Updated
February 16, 2023
Sponsor
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
1. Study Identification
Unique Protocol Identification Number
NCT05333302
Brief Title
Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
Official Title
Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Acute Lymphoblastic Leukemia, Lymphoblastic B-Cell Lymphoma
Keywords
immunotherapy, CAR-T cells, CD19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CD19 CAR-T cells immunotherapy
Arm Type
Experimental
Arm Description
After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells
Intervention Type
Biological
Intervention Name(s)
CD19 CAR-T-cells
Intervention Description
One dose of CD19 CAR-T cells (1*10e6 CAR+ T-cells/kg) by intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
Actemra
Intervention Description
Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Adverse events will be graded according to the CTCAE v5.0
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) (CR+CRi+CRm)
Description
The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), complete molecular remission (CRm).
Time Frame
28 days after CAR-T cells infusion
Title
Overall survival (OS)
Description
The proportion of patients with overall survival
Time Frame
1 year
Title
Events free survival (EFS)
Description
Time from CAR-T cells infusion to CR failure, relapse, or death.
Time Frame
1 year
Title
Leukemia free survival (LFS)
Description
Time from achievement of CR/CRi/CRm to the time of relapse, death in remission, or last follow-up.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Lukoyko, MD
Phone
+375291643075
Email
lenalukojko@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandr Meleshko, PhD
Phone
+375296940023
Email
meleshko@tut.by
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Aleinikova, MD, Prof
Organizational Affiliation
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Official's Role
Study Director
Facility Information:
Facility Name
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
City
Minsk
State/Province
Minsk Region
ZIP/Postal Code
223053
Country
Belarus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Lukoyko, MD
Phone
+37529 1643075
12. IPD Sharing Statement
Learn more about this trial
Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
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