Relapsed/Refractory B-cell ALL
Conditions
Brief summary
There are limited treatment options for relapse/refractory B-cell acute lymphoblastic leukemia(ALL). However,CART-19 cells has emerged as a powerful targeted immunotherapy for highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients with relapse/refractory B-cell ALL.
Interventions
CART-19 cells treat
Sponsors
Study design
Eligibility
Inclusion criteria
* Signed written informed consent * Aged between 1-60 years * Patients with relapsed/refractory B-cell 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