acute/chronic B lymphocytic leukemia
Conditions
Interventions
intervention group:anti-CD19 CAR-T cell therapy
Sponsors
Gansu Provincial Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. To be aged 1 to 75 years; 2. Patients with relapsed leukemia or primary drug resistance leukemia who have been diagnosed as CD19+ B-cell acute lymphoblastic leukemia: bone marrow relapsed after 1 or more bone marrow transplantation or allogeneic stem cell transplantation, or never CR after two chemotherapy, or patient with Philadelphia chromosome positive (Ph+), Or the patient cant tolerate chemotherapy and the treatment of tyrosine kinase inhibitors fails; 3. Relapsed patient with CD19 positive tumor cells in bone marrow or peripheral blood within 3 months; 4. Multiple organ function assessment: (1) kidney: serum creatinine level 60 mL/min / 1.73 m2; (2) Liver: ALT 91%; (4) Heart: confirmed by echocardiography or MUGA, left ventricular discharge index(LVEF) =45%; (5) lymphoblast > 5% in the bone marrow, confirmed by Morphology. 5. Estimated survival: 12 weeks to 2 years; 6. Patients with good compliance judge by doctors; 7. Voluntary participation in the clinical trials and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The HIV positive; 2. The obvious health or mental health does not apply to T cell therapy; 3. Fertility period women refused contraception after the treatment in 12 months; 4. Pregnancy and nursing females; 5. Suffering from other unrelated bone marrow disease and other hereditary syndromes, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome Fanconi anemia, Kostmann syndrome, Shwachman syndrome or other bone marrow disorder syndrome; 6. Activity and latency Hepatitis B, active hepatitis C or other severely uncontrollable infections, grade 2-4 acute and specific chronic graft-host rejection (GVHD); 7. Active central nervous system malignancy (CNS3); 8. Previously used any gene therapy products; 9. coagulation dysfunction; 10. Feasibility assessment Screening revealed that the proportion of target lymphocytes in peripheral blood mononuclear cells<30%, or the co-stimulatory response of target lymphocytes to CD3 / CD28 <5 × base value; 11. Those suffering from autoimmune diseases, organ transplantation need immunosuppressive therapy; 12. Severe uncontrolled infections, or other serious uncontrolled concomitant diseases; 13. Allergy to any interferon, interleukin 2 and the drug ingredients in the study; 14. Any unlisted active disease that may prevent the patient from participating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactZhang Qike
Department of Hematology, Gansu Provincial Hospital
Outcome results
None listed