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Open Label Phase II Study to Evaluate the Efficacy and Safety of Inotuzumab Ozogamicin for Induction Followed by Chemotherapy Consolidation and Maintenance Therapy In Patients Aged 56 Years and Older With Acute Lymphoblastic Leukemia (ALL)

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Trial Profile

Open Label Phase II Study to Evaluate the Efficacy and Safety of Inotuzumab Ozogamicin for Induction Followed by Chemotherapy Consolidation and Maintenance Therapy In Patients Aged 56 Years and Older With Acute Lymphoblastic Leukemia (ALL)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 15 Dec 2023

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At a glance

  • Drugs Inotuzumab ozogamicin (Primary) ; Asparaginase; Cyclophosphamide; Cytarabine; Dexamethasone; Idarubicin; Methotrexate; Rituximab
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Therapeutic Use
  • Acronyms GMALL-Initial1 Trial; INITIAL1

Most Recent Events

  • 15 Nov 2023 This trial has been discontinued, according to European Clinical Trials Database record.
  • 26 Oct 2023 Results (n=43) assessing safety and efficacy of Inotuzumab Ozogamicin as Induction Therapy for Patients Older Than 55 Years With Philadelphia Chromosome-Negative B-Precursor ALL published in the Journal of Clinical Oncology
  • 13 Dec 2022 Results(n=43) assessing safety and efficacy of Inotuzumab Ozogamicin Induction Followed By Standard Chemotherapy in Patients with De Novo B-Lymphoblastic Leukemia presented at the 64th American Society of Hematology Annual Meeting and Exposition

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