CD19 positive refractory/relapsed acute lymphoblastic leukemia or aggressive lymphoma
Conditions
Interventions
treatment group:infusion of UCART-19 cells
Sponsors
Guangdong Second Provincial General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pts diagnosed with CD19+ refractory/relapsed acute lymphoblastic leukemia or aggressive lymphoma. 2. Aged 18-70 years; 3. no evidences of CNS involved; 4. Minimal residual disease (MRD) load >= 1x10 ^-3; 5.Relapsing or refractory patients meet any of the following criteria: (1) Newly-diagnosed acute leukemia who did not achieve complete response after two courses of standard treatment; (2) Relapsing acute leukemia who did not achieve complete response after one course of standard treatment; (3) Acute leukemia who failed to achieve MRD negative after two courses of treatment; (4) Acute leukemia with secondary or multiple relapses; (5) Any relapses after allogeneic hematopoietic stem cell transplantation (allo-HSCT) , with an estimated interval between UCAR-T therapy and relapses > 3 months; (6) Lymphoma patients with the tumor volume reduced < 50% after two or more courses of rituximab-based standard treatment, or the progressive disease during chemotherapy, or the residue disease after four cycles of rituximab-based standard treatment, or the tumor shrinks/disappears but reappears, or new lesions appear. 6. ECOG status <= 2 for adults 7. The patient has self-knowledge, or the patient signs the power of attorney to authorize the client to sign the informed consent to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: 1. With the history suffered from other cancers; 2. Accepted other treatment targeting CD19; 3. With uncontroled II-IV acute GVHD or extensive chronic GVHD; 4. Heart failure with symptoms; left ventricular ejection fraction(LVEF) 2000IU/mL or HCV-RNA > 25IU/mL); 7. Serum total bilirubin>34umol/L (or 2.0 mg/dL) or ALT or AST > 3 ULN; 8. uncontrolled infections; 9. Human Immunodeficiency Virus (HIV) antibody positive patients; 10. female with pregnant or in lactation period; 11. other conditions may increas the risk of pts or may interfere the results of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete remission rate;progression-free survival; | — |
Countries
China
Contacts
Public ContactQing Zhang
Guangdong Second Provincial General Hospital
Outcome results
None listed