JULIET
A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Phase 2N = 93NCT02445248
- Population
- Adults with relapsed or refractory diffuse large B-cell lymphoma ineligible for, or progressing after, autologous haematopoietic stem-cell transplantation.
- Design
- International, single-arm pivotal phase 2 study of centrally manufactured tisagenlecleucel in adults with relapsed or refractory diffuse large B-cell lymphoma who were ineligible for, or had progressed after, autologous haematopoietic stem-cell transplantation. 93 patients received an infusion and were included in the efficacy evaluation; the median time from infusion to data cut-off was 14 months (range 0.1 to 26). Primary end point: best overall response rate (complete or partial response) judged by an independent review committee. ClinicalTrials.gov lists 115 enrolled.
- Primary endpoint
- ORR
- Arms
- Tisagenlecleucel (experimental, n = 93): Single infusion of centrally manufactured autologous anti-CD19 CAR T cells
- People
- Schuster SJ, senior author Maziarz RT
Show the numbers
| Endpoint | Analysis | Tisagenlecleucel | Control | Effect |
|---|---|---|---|---|
| ORRPatients who received an infusion and were included in the efficacy evaluation (93)Best overall response rate (complete or partial response) by independent review committee (stated primary end point). | primarySchuster 2019 | 52% (41–62%) | — | Complete responses in 40% and partial responses in 12% of patients. |
| Endpoint | Analysis | Tisagenlecleucel | Control | Effect |
|---|---|---|---|---|
| ORRPatients who received an infusion and were included in the efficacy evaluation (93)Best overall response rate (complete or partial response) by independent review committee (stated primary end point). | primarySchuster 2019 | 52% (41–62%) | — | Complete responses in 40% and partial responses in 12% of patients. |