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Phase IIIb Study for Relapsed/Refractory Pediatric/Young Adult Acute Lymphoblastic Leukemia Patients to be Treated With CTL019

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Phase IIIb Study for Relapsed/Refractory Pediatric/Young Adult Acute Lymphoblastic Leukemia Patients to be Treated With CTL019

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Sep 2024

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At a glance

  • Drugs Cyclophosphamide (Primary) ; Cytarabine (Primary) ; Etoposide (Primary) ; Fludarabine (Primary) ; Siltuximab (Primary) ; Tisagenlecleucel (Primary) ; Tocilizumab (Primary)
  • Indications Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Registrational
  • Sponsors Novartis; Novartis Pharma A.G.; 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
    • 01 Jun 2022 Results assessing Tisagenlecleucel in pediatric and young adult patients with Down syndrome-associated relapsed/refractory acute lymphoblastic leukemia from three trials (ELIANA [NCT02435849], ENSIGN [NCT02228096] and B2001X [NCT03123939) published in the Leukemia
    • 11 Nov 2020 Status changed from active, no longer recruiting to completed.

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