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ELARA

Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial

Phase 2N = 98NCT03568461

Population
Relapsed or refractory follicular lymphoma after two or more treatment lines, or relapse after autologous stem cell transplant; efficacy set 94, safety set 97.
Design
Phase 2 multinational trial of tisagenlecleucel in adults with relapsed or refractory follicular lymphoma after two or more treatment lines or relapse after autologous stem cell transplant. Primary endpoint: complete response rate. Primary prespecified interim analysis: 98 patients enrolled, 97 received tisagenlecleucel, 94 in the efficacy set.
Primary endpoint
CR rate
Arms
  • Tisagenlecleucel (experimental, n = 97): Tisagenlecleucel, single infusion
People
Fowler NH
Show the numbers
Results reported for ELARA
EndpointAnalysisTisagenlecleucelControlEffect
CR rateEfficacy set (94 patients)primarymedian follow-up 16.59 monthsFowler 202269.1% (58.8–78.3%)—Primary prespecified interim analysis; the primary endpoint was met.
ORREfficacy set (94 patients)primarymedian follow-up 16.59 monthsFowler 202286.2% (77.5–92.4%)——
Results reported for ELARA
EndpointAnalysisTisagenlecleucelControlEffect
CR rateEfficacy set (94 patients)primarymedian follow-up 16.59 monthsFowler 202269.1% (58.8–78.3%)—Primary prespecified interim analysis; the primary endpoint was met.
ORREfficacy set (94 patients)primarymedian follow-up 16.59 monthsFowler 202286.2% (77.5–92.4%)——
Primary publication: Fowler NH, Dickinson M, Dreyling M, Martinez-Lopez J, Kolstad A, Butler J, et al. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. Nat Med. 2022;28(2):325-332. PubMedDOI

Appears in

Sources

  1. Fowler NH, Dickinson M, Dreyling M, Martinez-Lopez J, Kolstad A, Butler J, et al. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. Nat Med. 2022;28(2):325-332.

    PubMedDOI