refractory and relapsed acute lymphoblastic leukemia
Conditions
Interventions
Cliniacal observation group:CD19CART Cell Therapy
Sponsors
Shanghai Children's Medical Center affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. CD19+ B-cell acute lymphoblastic leukemia; 2. Aged <18 years; 3. Can't achieve CR after 2 cycles of chemotherapy, cant find appropriate targeted drugs, and have no response to targeted drugs; 4. BM relapse, and can't achieve CR after chemotherapy; 5. First time of non-late relapse (CCR<36months), and cant find appropriate donor (un-related donor); 6. More than twice BM relapse, and cant find appropriate donor (un-related donor); 7. BM relapse after hematopoietic stem cell transplantation; 8. Voluntary participation in the clinical trials and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The estimated survival is over 12 weeks; 2. Creatinine>2.5 mg/dl; ALT, AST> 5 times ULN, Bilirubin > 2.0 mg/dl, LVEF<40%; 3. Systemic fungal, bacterial, viral, or other active infection that cant be controlled; 4. Active HBV/HCV infected or HIV infection; 5. Early loss to follow-up (<3 months); 6. Central nervous system leukemia (CNS-3); 7. Patients who relapse after HSCT with chimeric state, have GVHD, and need IST; 8. Other systemic diseases can intervene the clinic study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event;remission rate;relapse rate;Progression-Free-Survival;Overall survival; | — |
Countries
China
Contacts
Public ContactChen Jing
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed