Acute Lymphoblastic Leukemia
Conditions
Brief summary
CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of relapse as defined by MRD+ status.
Interventions
CART-19 cells treated
Sponsors
Study design
Eligibility
Inclusion criteria
* Signed written informed consent * Aged between 1-60 years * Patients with MRD positive CD19+ ALL * Cardiac: Left ventricular ejection fraction ≥ 50% * Adequate renal and hepatic function * Performance status: Karnofsky ≥ 70%
Exclusion criteria
* Pregnant or lactating females. * Any co-morbidity precluding the administration of CART-19 cells.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Leukemia free survival | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events that are related to treatment | 1 year |
Countries
China