Recurrent refractory b-cell acute lymphoblastic leukemia.
Conditions
Interventions
Cases:Car-t cell therapy
Sponsors
Affiliated Second Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The age at the time of the initial diagnosis is 18-70 years, regardless of sex and ethnicity; 2. Diagnosis of CD19-positive recurrence / difficulty in treating acute B-cell lymphoblastic leukemia(including the following); (1) Bone marrow morphology during screening showed that the original lymphocyte = 5 %; (2) Bone marrow recurrence after allogeneic hematopoietic stem cell transplantation, CAR-T 19 pre-transfusion SCT treatment greater than 6 months and in a recurrent state; (3) Difficult to treat patients(2 rounds of standard chemotherapy did not reach CR status); (4) Philly Chromosomal Positive(Ph +) Acute Lymphoblastic Leukemia and tyrosinase inhibitor(TKI) treatment failed twice or could not maintain CR. 3. Expected lifetime & GT; 12 weeks; 4. The main researchers and attending physicians believe that there are no other feasible and effective alternative treatments for patients, such as hematopoietic stem cell transplantation; 5. In patients with relapse, the expression of CD19 was detected in bone marrow or peripheral blood tumor cells 3 months before entering the group; 6. Expression of CD19 on lymphocytes: Flow fine 7. The main organs are functional and include: (1) Renal function: radioisotope glomerular filtration rate & GT; 60 mL/min, or serum creatinine clearance meeting the relevant age/gender criteria; (2) Alanine transferase(ALT) & lt; 5 times the normal standard maximum value; (3) 91 % bilirubin; (4) Echocardiography shows that the left ventricle short-axis shortening rate(LVSF) = 28 %, or the left ventricle ejection fraction(LVEF) = 45 %; 8. Zubrod-ECOG-WHO score = 2 points during screening; 9. Sign a written informed consent, which must be obtained before any research can be carried out; 10. Peripheral white blood cell count was normal; 11. When these other conditions are met, the cell culture plant must receive fresh blood samples from the patient. If it is a single line of cells, only the relevant test can be accepted by the cell culture plant.
Exclusion criteria
Exclusion criteria: 1. The recurrence of isolated extramedullary diseases; 2. Patients are accompanied by the following genetic syndrome: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any known bone marrow failure syndrome, and patients with Down syndrome are not included in the exclusion standard; 3. The patient had Burkitt's lymphoma / leukemia, and the morphology was L3 or MYC heterotopic expression in the FAB classification; 4. In the past, there was a history of malignant tumors, but patients with in situ cancer of the skin or cervix and patients with inactive tumors were not included in the exclusion criteria; 5. Past use of gene therapy; 6. Previous use of anti-CD19/CD3 combination therapy or any other anti-CD19 treatment; 7. Screening for hepatitis B or C or HBV/HCV, or with other uncontrolled infections; 8. Screening is accompanied by HIV infection; 9. II degree-IV degree acute or chronic graft anti-host reaction(GVHD); 10. Treatment with the following drugs: (1) Steroids: CAR-T19 banned within 72 hours prior to transfusion (2) Allogeneic cell therapy: CAR-T19 can not perform any donor lymphocyte infusion(DLI) within 6 weeks before retransmission; (3) GVHD treatment: CAR-T19 must stop any GVHD treatment within 4 weeks before retransmission(such as calcium tamponase inhibitors, methotrexate, methophenolic esters, steroids(see above), rapamycin, Thalidomide or immunosuppressive antibodies, Such as anti-CD20/TNF/IL6/IL6R); (4) Chemotherapy: (5) The following drugs will be discontinued at least 1 week before CAR-T 19. At the same time, it is best not to accompany lymphocyte elimination chemotherapy programs: hydroxyurea, vincristine, 6-mercapine, 6-thioguanine, methotrexate, adenosine(dose 100 mg/m2), anthracycline drugs, cyclophosphamide; (6) Central nervous system(CNS) disease prevention: CNS prevention treatment stops at least before CAR-T 19 intakes 11. Pregnant or lactating women: female test participants were tested for serum or urinary pregnancy 48 hours before returning to the test. The test results were positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone marrow primitive cells; | — |
Countries
China
Contacts
Public ContactYan Jinsong
Affiliated second Hospital of Dalian Medical University
Outcome results
None listed