Refractory.relapsed acute lymphoblastic luekemia
Conditions
Interventions
Experimental group:Fast-CAR-T cell
Sponsors
Xinqiao Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or Femal aged from 14 to 70 years; 2. Refractory/relapsed B cell acute lymphoblastic leukemia with the anyone of following conditions: (1) Relapse: Two or over two times relapse or relapse after allogeneic hematopoietic stem cell transplantation with 5% blast cells; (2) Refractory: No CR after chemotherapy with two cyles; (3) The ph+ B-ALL with the anyone of following conditions: 1) Cant tolerant TKI; 2) Progression of the first and the second KTI; 3) Unfitable for allogeneic hematopoietic stem cell transplantation; 3. The CD19 was positive in the leukemia cells; 4. ECOG performance status of = 1x10^9/L; 7. PLT >= 75 x 10^9/L; 8. ALC >= 100/uL; 9. Adequate main organ function: (1) Liver function: ALT/AST = 95%; (4) Heart: ejection fraction > 40 %; 1) Liver: ALT/AST =60mL/min; 3) Total bilirubin =50% without hydropericardium and abnormal electrocardiogram; 5) Ward with natural air and oxygen saturation > 92%; 10. HIVHBVHCVTPPA and HTLV are negative before six weeks of the T cell collection (ELISA); 11. CMVEBV and B19 are negative before six weeks of the T cell collection (qPCR); 12. HCG is negative during screening and before chemotherapy and contraception was agreement during treatment; 13. Understand and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Extramedullary relapse; 2. The blast cells in peripheral blood >= 90%; 3. With other cancer except the patients with non-melanomaskin cancercervical carcinoma in situbladder cancer and breast cancer and so on for over 5-year disease-free survival; 4. Serious psychiosis; 5. Genetic disease, such as Fanconi anemia, Shwachman-Diamond syndrome, Kostmann's syndrome or other bone marrow failure syndrome; 6. With aGVHD or extensive cGVHD with grade II-IV; 7. Heart failure with grade III-IV, myocardial infarction, cardioangioplasty or cardiac stenting, unstableangina or other heart disease with clinical complication before one year of study; 8. With catheters or drainage tube except central venous catheter; 9. Leukemia in the CFS or brain metastases of cancer or CNS lymphoma; 10. History of central nervous system diseases, such as Epileptic seizures, Cerebrovascular ischemia or bleeding, dementia, cerebellar diseases, autoimmune disease of CNS disease; 11. Intravenous infusion against serious infection of fungus, bacterium, virus; 12. Allergy or serious history of allergy; 13. Autoimmune disease caused injury of terminal organ or need of systemic immunosuppression in the past two years, such as crohn's disease, rheumatoid arthritis, systemic lupus erythematosus; 14. With interstitial lung disease such as lung fibrosis or pneumonia; 15. Received gene treatment or CAR-T cells in the past; 16. Received any drugs targeted CD19; 17. Join the clinical trial within four weeks; 18. Low compliance or cant comply with research proposal and follow-up; 19. Contraindication for cyclophosphamide or fludarabine; 20. Patients need treatment with systemic corticosteroids (>=5mg/d) or immunosuppressive drugs except the treatment of adverse events; 21. The contraindication of drugs for the treatment of GVHD judged by the researchers; 22. Received donor lymphocyte infusion within six weeks; 23. Patients can not be enrolled which will be judged by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limited toxicity;adverse event;Proliferation of CAR-T cell; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;progression-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactZhang Xi
Xinqiao Hospital, Army Medical University
Outcome results
None listed