refractory and relapsed B cell hematological maliganacies
Conditions
Interventions
one:autologous CAR-Tcells
Sponsors
The first affiliated hospital of Xi'an Jiaotong university
Eligibility
Sex/Gender
All
Age
14 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical trials and sign the informed consent; 2. To be aged 14 to 60 years; 3. Patients diagnosed as B cell hematological disease included ALL,CLL,FL,MZL,LPL,DLBCL,BL,MCL,ALCL; 4. Refractory B cell hematological disease not eligible or appropriate for auto-HSCT or allo-HSCT or relapsed after HSCT;stop immuosupression drugs for at least 2 weeks in Allo-HSCT patients; 5. Organ function meeting following criteria: liver function: ALT/AST < 2 times the upper limit of normal, normal bilirubin; Renal function: creatinine is less than 2.5 mg/dl; Lung function: peripheral blood oxygen saturation is more than 90%; Heart function: left ventricular ejection fraction of 60%; 6. the subjects into groups do not accept any chemotherapy, radiation therapy, or immunosuppressive therapy before 2 weeks; 7. ECOG score less than 2.
Exclusion criteria
Exclusion criteria: 1. pregnancy or lactation women or nearly 1 years have conceived plan; 2. uncontrolled infection 2 weeks before enrolled the group; 3. patients with active hepatitis B or hepatitisC, HIV infection; 4. other cancer patients excpet B cell hematological disease; 5. with severe autoimmune diseases or immunodeficiency disease; 6. patients allergic to cytokines, etc; 7. used glucocorticoid within 1 week before enrolled into the group; 8. patients with mental illness; 9. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate;Progression Free Survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse reactions; amplification and duration of CART;T cell subgroup;Immunoglobulin concentration; | — |
Countries
China
Contacts
Public ContactZHANG MEI
The first affiliated hospital of Xi'an Jiaotong university
Outcome results
None listed