Pilot Study of Redirected Autologous T-cells Engineered to Contain Anti-CD19 Attached to TCR and 4-1BB Signaling Domains in Patient With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma (NCT01029366); Phase I/IIA Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRzeta and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant Or Refractory CD19+ Leukemia and Lymphoma (NCT01626495)
- Population
- Children and adults with relapsed or refractory acute lymphoblastic leukemia treated with CTL019 (30 patients in the 2014 report)
- Design
- CTL019 (CART19) autologous CD19 CAR T-cell therapy studied in two registered University of Pennsylvania-sponsored studies (a pilot study, NCT01029366, registered as phase 1, and NCT01626495, registered as phase 1/2). The 2013 report describes two children, the first two patients enrolled on NCT01626495 (Grupp 2013, Methods, which calls it a phase 1 trial); the 2014 report describes 30 children and adults with relapsed or refractory ALL who received CTL019, with results read from the abstract.
- Arms
- CTL019 (CD19 CAR T cells) (experimental, n = 30): Infusion of autologous T cells transduced with a CD19-directed chimeric antigen receptor lentiviral vector (CTL019), 0.76 to 20.6 million cells per kilogram
- People
- Maude SL
Show the numbers
| Endpoint | Analysis | CTL019 (CD19 CAR T cells) | Control | Effect |
|---|---|---|---|---|
| Complete remission ratePatients who received CTL019 (30 children and adults)Complete remission after CTL019 infusion, as reported in the 2014 paper | interimMaude 2014 | 90% | — | 27 of 30 patients; this included 2 patients with blinatumomab-refractory disease and 15 who had undergone stem-cell transplantation. |
| EFSPatients who received CTL019 (30 children and adults) | interimMaude 2014 | 67% at 6 mo (51–88%) | — | — |
| OSPatients who received CTL019 (30 children and adults) | interimMaude 2014 | 78% at 6 mo (65–95%) | — | — |
| Endpoint | Analysis | CTL019 (CD19 CAR T cells) | Control | Effect |
|---|---|---|---|---|
| Complete remission ratePatients who received CTL019 (30 children and adults)Complete remission after CTL019 infusion, as reported in the 2014 paper | interimMaude 2014 | 90% | — | 27 of 30 patients; this included 2 patients with blinatumomab-refractory disease and 15 who had undergone stem-cell transplantation. |
| EFSPatients who received CTL019 (30 children and adults) | interimMaude 2014 | 67% at 6 mo (51–88%) | — | — |
| OSPatients who received CTL019 (30 children and adults) | interimMaude 2014 | 78% at 6 mo (65–95%) | — | — |