B-cells lymphoma
Conditions
Interventions
Case series:Radiotherapy was followed by CD19CART infusion
Sponsors
Tianjin First Central Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 5 to 80 years; 2. Histologically confirmed CD19+ diffuse large b cell lymphoma; 3. localised stage, with measurable lesions, the longest diameter no less than 6.0cm; 4. ECOG Performance Status 0-2; 5. Estimated time of survival more than 3 months; 6. white blood cell 4 x 10^9/L - 10x10^9/L, lymphocyte 1.1x10^9/L - 3.2x10^9/L, haemoglobin = 80g/L, PLT = 60x10^9/L; 7.The functioning of important viscera being normal: cardiac ultrasound indicates that cardiac ejection fraction = 50%, and the ECG being not significantly abnormal. The blood oxygen content is = 90%. Creatinine clearance rate (by CG formula) = 60ml/min; ALT and AST 3.0xULN; Serum bilirubin and alkaline phosphatase 2.0xULN; Blood potassium and sodium is normal; Serum lipase and amylase < 1.5 x ULN; Serum Alb = 30 g/L; 8. with adequate intravenous access for a single blood collection or intravenous blood collection, and no other blood cell separation contraindications; 9. Women of childbearing age with a negative pregnancy test; 10. Agrees to take active contraceptives measure during and 3 month after the trial; 11. Agrees to the 24-week assessment schedule and follow-up plan and to cooperate actively; 12. Give signed informed consent before enrollment.
Exclusion criteria
Exclusion criteria: 1.Participated in other clinical trials in the last 3 months; 2.Pregnant or lactating women; 3.HIV positive; 4.Clinically severe heart disease (NYHA) of Grade II or more severe congestive heart failure, or severe arrhythmia requiring drug interventionor some other functional insufficiency of vital organs; 5.Uncontrollable hypothyroidism or hyperthyroidism 6.Suffering from congenital immune deficiency disease or bone marrow deficiency disease; 7.Uncontrollable epilepsy, central nervous system disease, cerebral vascular accident or having history of mental disorders; 8.With history of other malignancies in the last 5 years (except for cured skin and cervical in situ); 9.Uncontrollable active infection; 10.Anyone who the researchers think unsuitable to participate in the investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete remission rate;Radiotherapy associated mortality;six cytokines, procalcitonin and C-reactive protein, etc.;T cell subsets;the positive rate of CD19CART;Overall survival;Progression-free survival; | — |
Countries
China
Contacts
Public ContactMingfeng Zhao
Department of hematology, Tianjin First Central Hospital
Outcome results
None listed