refractory or relapsed acute lymphoblastic leukemia
Conditions
Interventions
treatment group:anti-CD19 (human derived) cell immunotherapy
Sponsors
Beijing Boren Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Primary refractory or chemotherapeutic relapsed acute lymphoblastic leukemia (ALL) patients who have been diagnosed as CD19+ positive(> 95% of leukemia cells express CD19)(In line with NCCN,2018.V1), or patients with hematologic relapse after drug withdrawal who can't achieve CR after 1 cycle of chemotherapy; 2. Aged 1 to 70 years; 3. Patients with self-awareness and older than 18 years, who have the ability to sign the consent form and voluntary consent; 4. Pediatric patients' legal guardians or the clients authorized by patients sign the consent form and are voluntary to participate in the clinical trials.
Exclusion criteria
Exclusion criteria: 1. Intracranial hypertension or unconsciousness; 2. Symptomatic heart failure or severe cardiac arrhythmia; 3. Respiratory failure; 4. With other types of malignant tumors; 5. Disseminated intravascular coagulation; 6. Serum creatinine and/or urea nitrogen>=1.5xnormal; 7. Sepsis or other uncontrolled active infection; 8. Uncontrolled diabetes; 9. Severe mental disorder; 10. Obvious intracranial lesions examined by head MRI; 11. Cerebrospinal fluid leukemia cells> 20/ul; 12. Ratio of blood leukemia cell > 30%; 13. WHO physical status classification level >= 3; 14. Organ transplant recipients; 15. Pregnant or lactating women; 16. After culture, the total number of CD19-CART cells did not reach the standard of backtransfusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;complete remission rate;Progression-free survival (PFS); | — |
Countries
China
Contacts
Public ContactShuangyou Liu
Beijing Boren Hospital
Outcome results
None listed