A Phase 1/2 interventional study of Chimeric Antigen Receptor T-Cell Therapy and Fludarabine in B-cell Acute Lymphoblastic Leukemia and Acute Lymphocytic Leukemia, Pediatric, sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology. Active, not recruiting at 1 site in Russian Federation. Open to participants aged 3 Months to 25 Years. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Phase 1/2, Interventional, and Treatment
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
The main objectives of the study are:
The novelty of this study will be cytokine release syndrome prophylaxis by tocilizumab Patients will receive fludarabine 120 mg/m2 (totally) intravenously (IV) over 30 minutes on days -5 to -2 and cyclophosphamide 750 mg/m2 IV over 60 minutes on day -2. One hour prior to infusion of CAR T-cells patients will receive tocilizumab IV 8 mg/kg (max 800 mg) over 1 hour. Patients then receive CD19-CAR T cells IV over 20-30 minutes on day 0.
This is a dose-escalation study of CD19-CAR T cells. Dose escalation consistently:
Based on interim analysis the following dosing approach based on stratification by the initial leukemia burden will be implemented starting November 2019:
CD19 CAR-T cells will be infused IV in dose 1x106/kg on day 0.
CD19 CAR-T cells 1st dose will be infused IV on day 0 - 0,1x106/kg, 2nd dose will be infused IV between day 7 and 14 - 0,9x106/kg.
976 studies on the registry are indexed under Burkitt Lymphoma; 159 are open to participants now.
This study's planned enrollment of 18 is below the median of 36 across 765 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →Federal Research Institute of Pediatric Hematology, Oncology and Immunology is the lead sponsor of 57 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with CD19-expressing B cell ALL :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive lymphodepleting chemotherapy, one hour prior to infusion of CAR T-cells patients will receive tocilizumab IV 8 mg/kg (max 800 mg) over 1 hour. Patients then receive CD19-CAR T cells IV on day 0.
Biological: Chimeric Antigen Receptor T-Cell Therapy · Drug: Fludarabine · Drug: Cyclophosphamide · Drug: Tocilizumab · Drug: Cytarabine · Drug: Etoposide · Drug: Dexamethasone
Drug page: Chimeric Antigen Receptor T-cells
anti-CD19 chimeric antigen receptor - transduced T-cell given IV
given IV
given IV
given IV
given IV
given IV
given IV
Incidence of grade 3-5 SAE occurring within 30 days of CD19CAR T-cell infusion
incidence of grade 3-5 SAE according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 occurring within 30 days of CD19CAR T-cell infusion
Time frame: 1 month
Incidence of grade 3-4 Severe Cytokine Release Syndrome following CD19 CAR T-cell infusion
incidence of grade 3-4 Severe Cytokine Release Syndrome
Time frame: 1 month
Incidence of grade 3-5 neurotoxicity occurring within 30 days of CD19 CAR T-cell infusion
incidence of grade 3-5 neurotoxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 occurring within 30 days of CD19 CAR T-cell infusion
Time frame: 1 month
Proportion of patients in MRD-negative remission
Proportion of patients in MRD-negative remission among all enrolled patients
Time frame: 1 month
Proportion of patients in hematologic remission
Proportion of patients in hematologic remission among all patients with morphological disease (NO CR) at enrollment
Time frame: 1 months
Duration of MRD-negative remission
Duration of MRD-negative remission
Time frame: 2 years
Persistence/frequency of CD19 CAR T lymphocytes in peripheral (FC+qPCR)
Persistence/frequency of CD19 CAR T lymphocytes in peripheral (FC+qPCR)
Time frame: 2 years
Duration of B-cell aplasia
Duration of B-cell aplasia and hypogammaglobulinemia, time 0 - day of CD19-CAR T cells infusion
Time frame: 5 years
Overall survival
the probability of survival, time 0 - day of CD19-CAR T cells infusion
Time frame: 5 years
This study is active, not recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Chimeric Antigen Receptor T-cells · Fludarabine · Cyclophosphamide · Tocilizumab · Cytarabine · Etoposide · Dexamethasone
Federal Research Institute of Pediatric Hematology, Oncology and Immunology