Chemotherapy resistant or refractory B cell malignancy
Conditions
Interventions
experimental group:therapy by CART
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Mail and femail patients with CD19+ B cell acute lymphoblastic leukemia who meet the following conditions (1) Multiple relapse after chemotherapy; (2) Non remission after multiple chemotherapy; (3) relapse after allogeneic transplantation; (4) No remission before allogeneic transplantation; (5) Not eligible or appropriate for allogeneic stem cell transplantation. 2. Mail and femail patients with CD19+ B cell chronic lymphoblastic leukemia,lymphoma who meet the following conditions: (1) Did not reach PR after 4 courses of first-line treatment; (2) Less than 1 years between the last chemotherapy and progression; (3) Repeated relapse; (4) Relapse after allo-genetic or atuo-genetic transplantation; 3. Age 18-60 years 4. Expected survival > 12 weeks; 5. Women must be unpregnancy before trail, and be contracepted during the trial period and until follow-up for the last time; 6. Volunteer who participate in this experiment agree and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women(the safety of the unborn child is still unknown); 2) Has a history of epilepsy or other central nervous system disease; 3) People with QT interval prolongation or serious heart disease; 4) People who suffer from other diseases that are not controlled, the researchers believe that the person who is not suitable to be added; 5) creatinine>2.5mg/dl or ALT / AST>3 times normal amount or bilirubin>2.0 mg/dl; 6) Presence of grade 2-4 acute or extensive chronic GVHD; 7) Under treatment for GVHD; 8) Uncontrolled active infection; 9) Active hepatitis B or hepatitis C virus infection; 10) HIV infected persons; 11) Use of systemic steroids before treatment within 2 weeks(except for the recent or current use of inhaled steroids); 12) Previous treatment with any gene therapy products; 13) The efficiency of T cells transduced by replication-deficient lentivirus was less than 30%,or insufficient amplification (<5times)when respond the CD3 / CD28 costimulation signal; 14) central nervous system involvement of leukemia patients; 15) Any situation that may increase the risk of the test or interfere with the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression- Free Survival;Overall Survival;Response Rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| relapse rate;Non-Relapse Mortality;Infection Rate; | — |
Countries
China
Contacts
Public ContactLi Yuhua
Outcome results
None listed