Skip to content
Bending the Curve Trial by Trial
?

ELIANA

A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia

Phase 2NCT02435849

Population
Pediatric and young adult patients with CD19+ relapsed or refractory B-cell acute lymphoblastic leukemia
Design
Phase 2, single-cohort, 25-centre global study of tisagenlecleucel; results shown are the planned analysis reported in 2018.
Primary endpoint
Overall remission rate
Arms
  • Tisagenlecleucel (experimental, n = 75): Single infusion of tisagenlecleucel (anti-CD19 CAR T cells)
People
Maude SL, senior author Grupp SA
Show the numbers
Results reported for ELIANA
EndpointAnalysisTisagenlecleucelControlEffect
Overall remission ratePatients infused and evaluable for efficacy (75)Complete remission or complete remission with incomplete hematologic recovery within 3 monthsprimaryMaude 201881%—All patients with a response were negative for minimal residual disease by flow cytometry; median duration of remission not reached.
EFSPatients infused and evaluable for efficacy (75)primaryMaude 201873% at 6 mo (60–82%); 50% at 12 mo (35–64%)——
OSPatients infused and evaluable for efficacy (75)primaryMaude 201890% at 6 mo (81–95%); 76% at 12 mo (63–86%)——
Results reported for ELIANA
EndpointAnalysisTisagenlecleucelControlEffect
Overall remission ratePatients infused and evaluable for efficacy (75)Complete remission or complete remission with incomplete hematologic recovery within 3 monthsprimaryMaude 201881%—All patients with a response were negative for minimal residual disease by flow cytometry; median duration of remission not reached.
EFSPatients infused and evaluable for efficacy (75)primaryMaude 201873% at 6 mo (60–82%); 50% at 12 mo (35–64%)——
OSPatients infused and evaluable for efficacy (75)primaryMaude 201890% at 6 mo (81–95%); 76% at 12 mo (63–86%)——
Illustrative — modelled from reported values, not trial data. EFS, primary.
0%25%50%75%100%024681012Months (modelled)
  • Tisagenlecleucel (experimental)
Data table (modelled values)
MonthsTisagenlecleucel
0100.0%
386.3%
673.0%
1057.5%
1350.0%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%024681012Months (modelled)
  • Tisagenlecleucel (experimental)
Data table (modelled values)
MonthsTisagenlecleucel
0100.0%
395.3%
690.0%
1080.8%
1376.0%
Primary publication: Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, et al. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. N Engl J Med. 2018;378(5):439-448. PubMedDOI

Appears in

Sources

  1. Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, et al. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. N Engl J Med. 2018;378(5):439-448.

    PubMedDOI