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A Phase I study of Inotuzumab Ozogamicin as a single agent for pediatric patients in Japan with relapsed/refractory CD22-positive Acute Lymphoblastic Leukemia

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Trial Profile

A Phase I study of Inotuzumab Ozogamicin as a single agent for pediatric patients in Japan with relapsed/refractory CD22-positive Acute Lymphoblastic Leukemia

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 28 May 2024

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At a glance

  • Drugs Inotuzumab ozogamicin (Primary)
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions
  • Acronyms INO-Ped-ALL-1

Most Recent Events

  • 27 May 2024 According to the Pfizer Media Release, based on results from two clinical trials (INO-Ped-ALL-1 and ITCC-059), company today announced that it has received approval for a partial change in drug manufacturing and marketing approval items for Besponsa in Japan for the treatment of pediatric relapsed or refractory CD22-positive acute lymphoblastic leukemia
  • 27 May 2024 According to the Pfizer Media Release, the company submitted an application today, for approval of a partial change to the manufacturing and marketing approval items for inotuzumab ozogamicin (recombinant) preparation "Besponsa", is application is based on the results of a domestic Phase 1 study (INO-Ped-ALL-1 study: investigator-initiated clinical trial) and an overseas Phase 1/2 study (ITCC-059 study: investigator-initiated clinical trial).
  • 01 Oct 2022 Results published in the International Journal of Hematology

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