16CT022: A Phase 2 two cohort study of the tocilizumab optimization timing for CART19 (CTL019) associated cytokine release syndrome (CRS) management in pediatric patients with CD19 expressing relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) (CHOP IRB # 16-013097)

CART-19 cells transduced with a lentiviral vector to express either anti-CD19 scFv TCR:41BB, administered by i.v. injection using an intra-patient dose escalation approach: 10% on day 0, 30% on day 1 with a total dose goal of ~1.5 x10^7 5 x10^9 (~0.3x10^6 - 1.0x10^8/kg) T cells. Two cohorts are defined based upon pre-infusion high versus low tumor burden; with the high tumor burden cohort to receive protocol defined early anti-cytokine intervention (i.e. tocilizumab) for CRS management and the low tumor burden cohort to receive standard anti-cytokine intervention (i.e. tocilizumab) for CRS. All screening, enrollment, treatment and follow-up procedures will take place at CHOP only. Activity at the University of Pennsylvania is limited to sponsor-related responsibilities, including data analysis/review, collection and analysis of research samples from CHOP subjects for the manufacturing of investigational product by CVPF, and site monitoring per the study DSMP.

You may be eligible for this study if you meet the following criteria:

• Conditions: TBD, tbd, tbd
• Age: 99 years or below
• Gender: All