R/R B-cell leukemia
Conditions
Interventions
Single arm:CAR-T cell Infusion
Sponsors
Shanghai Children's Medical Center affiliated to Medical College of Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: Patients with refractory or recurrent B-cell hematological tumors (leukemia and lymphoma) have good clinical compliance and meet at least one of the following conditions: 1. Patients who did not respond to induction chemotherapy twice or more (primordial + immature cells > 5%); 2. Patients with MRD > 1% on the 46th day of chemotherapy; 3. Patients with MRD increased at least twice during the initial treatment, of which MRD > 1% at least once; 4. For patients with bone marrow relapse at any time, MRD > 0.1% after induction chemotherapy; 5. Patients with relapse of pure extramedullary leukemia (testicular leukaemia or meningeal leukaemia); 6. CD19 positive patients with B-series lymphoid system tumors in the advanced stage of the disease; 7. The guardians of all enrolled children need to sign the informed consent form (if the children are over 10 years old, in addition to the informed consent form signed by the guardians, the patients themselves should also sign to express their consent to participate in this study), and they should be treated according to the decision of the ethics committee.
Exclusion criteria
Exclusion criteria: 1. Subjects over 18 years old; 2. Patients whose expected survival time is less than 12 weeks; 3. Subjects with CD19 antigen mutation or structural variation in gene detection; 4. Patients with relapsed GVHD after bone marrow transplantation need immunosuppressant intervention; 5. In patients with relapse time less than 3 months after bone marrow transplantation, no donor can be found; 6. Creatinine > 2.5mg/dl; ALT / AST > 5 times of normal; total bilirubin > 2mg / dl; 7. Patients with uncontrollable active infection; 8. Patients with active hepatitis B and C, or HIV infection; 9. Patients who were lost to follow-up early (< 3 months) after treatment; 10. Patients with other systemic diseases that interfere with this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRD;Cytokine Releasw Syndrome;Overall Survival;Event-free Survival; | — |
Countries
China
Contacts
Public ContactBenshang Li
Shanghai Children's Medical Center affiliated to Medical College of Shanghai Jiaotong University
Outcome results
None listed