B-cell Acute Lymphoblastic LeukemiaPhase 1NCT05333302
Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
A Phase 1 study testing CD19 CAR-T-cells and Tocilizumab in people with B-cell Acute Lymphoblastic Leukemia and Lymphoblastic B-Cell Lymphoma, run by Belarusian Research Center for Pediatric Oncology, Hematology and Immunology at 1 site in Belarus.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia, Lymphoblastic B-Cell Lymphoma
- What is being tested?
- CD19 CAR-T-cells and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelarus
- Study dates
- 26 Oct 2020to Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Belarus1 site, 1 recruiting
- Recruiting
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Minsk, Minsk Oblast, 223053
Elena Lukoyko, MD, +37529 1643075
About this study
Official title: 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.
Read the 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.
- Being tested
- CD19 CAR-T-cells, Tocilizumab
- Keywords
- immunotherapy, CAR-T cells, CD19
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR-T-cellsBiological
One dose of CD19 CAR-T cells (1*10e6 CAR+ T-cells/kg) by intravenous infusion.
TocilizumabDrug
Also called Actemra
Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| CD19 CAR-T cells immunotherapy | Experimental | After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells Receives: Biological: CD19 CAR-T-cells; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Adverse events will be graded according to the CTCAE v5.0
Measured: 1 month
Secondary outcomes (4)
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).
Measured: 28 days after CAR-T cells infusion
Overall survival (OS)
The proportion of patients with overall survival
Measured: 1 year
Events free survival (EFS)
Time from CAR-T cells infusion to CR failure, relapse, or death.
Measured: 1 year
Leukemia free survival (LFS)
Time from achievement of CR/CRi/CRm to the time of relapse, death in remission, or last follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start26 Oct 2020
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga Aleinikova, MD, Prof, Study director, Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333302
- Sponsor's protocol ID
- CD19CAR-T_LL_children
- Status last verified
- Aug 2024
- First submitted
- 12 Apr 2022
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults
- ClinicalTrials.gov ID
- NCT05333302
- Acronym / sponsor ID
- CD19CAR-T_LL_children
- Keywords
- immunotherapy, CAR-T cells, CD19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Belarusian Research Center for Pediatric Oncology, Hematology and ImmunologyUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19 CAR-T cells immunotherapy | Experimental | Biological: CD19 CAR-T-cells, Drug: TocilizumabAfter a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD19 CAR-T-cellsOne dose of CD19 CAR-T cells (1*10e6 CAR+ T-cells/kg) by intravenous infusion. | Biological | CD19 CAR-T cells immunotherapy |
| TocilizumabAlso: ActemraBefore 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg). | Drug | CD19 CAR-T cells immunotherapy |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 1 month
Adverse events will be graded according to the CTCAE v5.0
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Aleinikova, MD, Prof study director
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD19 CAR-T-cells and Tocilizumab in people with B-cell Acute Lymphoblastic Leukemia and Lymphoblastic B-Cell Lymphoma, run by Belarusian Research Center for Pediatric Oncology, Hematology and Immunology at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Lukoyko, MD (+375291643075, lenalukojko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.