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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 22 Jan 2024

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At a glance

  • Drugs Tisagenlecleucel (Primary)
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Therapeutic Use
  • Acronyms ENSIGN
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 12 Dec 2023 Results of analysis assessing impact of CAR persistence and B cell aplasia on duration of remission based on long term follow up data from pivotal phase II studies in patents with r/r ALL (ELIANA, ENSIGN, NCT03123939, NCT01626495), r/r DLBCL (JULIET), and r/r FL (ELARA), along with the long term follow up study (NCT02445222) presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 07 Dec 2023 According to a BostonGene media release, data from this trial will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition 2023.
    • 09 Nov 2022 Results (n=206) assessing the influence of household poverty and neighborhood social determinants on outcomes from CAR T-cell therapy for relapsed/refractory leukemia from (NCT01626495; NCT02435849 ; NCT02374333; NCT02228096; NCT02906371) clinical trials and commercial tisagenlecleucel from 2012 to 2020, published in the Blood.
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