Status:
COMPLETED
Phase II Study of Anti-CD19 CAR-T Cells Treating Leukemia Children
Lead Sponsor:
Beijing Boren Hospital
Conditions:
Acute Lymphoblastic Leukemia, Pediatric
Acute Lymphoblastic Leukemia, in Relapse
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief Summary
The investigators will conduct a phase II clinical trial of autologous murine anti-CD19 chimeric antigen receptor T cells treating refractory or relapsed B acute lymphoblastic leukemia children in Bei...
Eligibility Criteria
Inclusion
- Patients who were diagnosed as primary refractory or relapsed B-ALL. All the patients matched the diagnostic criteria of ALL according to the WHO classification and conducted morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis, screen of 56 leukemia-related fusion genes by multiplex nested reverse transcriptase-polymerase chain reaction (RT-PCR), and quantification of fusion genes by real-time PCR with ABL1 as reference. Extramedullary diseases (EMDs) were confirmed CD19+ by FCM and evaluated by positron emission tomography/computed tomography (PET/CT), CT, MRI or ultrasonography. The patient relapsed during chemotherapy or failed from re-induction chemotherapy (including first and second-generation TKIs) after relapse or had a persistent positive minimal residual disease (MRD) for three months. Patients had positive CD19 expression on leukemia blasts by FCM (\>95% CD19 positive);
- Age from 0 to 18 years old;
- Children candidates can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form;
Exclusion
- Intracranial hypertension or unconscious;
- Acute heart failure or severe arrhythmia;
- Acute respiratory failure;
- Other types of malignant tumors;
- Diffuse intravascular coagulation;
- Serum creatinine and/or blood urea nitrogen over 1.5 times than normal range;
- Sepsis or other uncontrolled infection;
- Uncontrolled diabetes mellitus;
- Severe psychological disorder;
- Obvious cranial lesions with cranial MRI;
- More than 20 counts/ul leukemic cells in cerebrospinal fluid;
- More than 30% leukemic cells in the blood;
- Stage III WHO/ECOG score;
- Organ recipients;
- Pregnant or breastfeeding;
- Active, uncontrolled infection, including hepatitis B, hepatitis C or human immunodeficiency virus (HIV);
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04325841
Start Date
March 24 2022
End Date
April 3 2024
Last Update
May 18 2025
Active Locations (1)
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1
Beijing Boren Hospital
Beijing, Beijing Municipality, China, 100000