relapsed or refractory B acute lymphoblastic leukemia
Conditions
Interventions
treatment group:anti-CD22 Chimeric Antigen Receptor T-Cell Immunotherapy
Sponsors
Beijing Boren Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with primary drug resistance leukemia or with relapsed leukemia during chemotherapy who have been diagnosed as CD19+ B-cell acute lymphoblastic leukemia, or patients with hematologic relapse who can't achieve CR after 1 cycle of chemotherapy, or patients with hematologic relapse whose leukemia is CD22 positive after CD19-CART treatment (> 95% of leukemia cells express CD22)(In line with NCCN,2015.2); 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=1.5 ×normal; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;Ratio of bone marrow and peripheral B leukemia cells; | — |
Countries
China
Contacts
Public ContactChunrong Tong
Beijing Boren Hospital
Outcome results
None listed