chemotherapy resistant or refractory leukemia
Conditions
Interventions
1:autologous Car-Tcells
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with CD19+ leukemia, meeting the following criteria: (1) At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy); (2) Less than 1 year between last chemotherapy and progression; (3) Not eligible or appropriate for allo-HSCT. 2. To be aged 12 to 70 years; 3. Estimated survival of >=6 months, but <=2 years; 4. ECOG score <=2; 5. Relapse after auto-HSCT; 6. Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time; 7. Voluntary participation in the clinical trials and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. History of epilepsy or other CNS disease; 2. Patients have GVHD, which needs treatment with immunosuppressive agents; 3. Patients with prolonged QT interval or severe heart disease; 4. Patients in pregnancy or breast-feeding period; 5. Uncontrolled active infection; 6. Active hepatitis B or hepatitis C infection; 7. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary; 8. Previously treatment with any gene therapy products; 9. Feasibility assessment during screening demonstrates 3*normal value; Creatinine> 2.5 mg/dl; Bilirubin >2.0 mg/dl; 11. Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial; 12. HIV infection; 13. 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; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Safety;Disease Free Survival; | — |
Countries
China
Contacts
Public ContactLiang Aibin
Outcome results
None listed