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A phase I/II study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia

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Trial Profile

A phase I/II study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 May 2024

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At a glance

  • Drugs Inotuzumab ozogamicin (Primary) ; Antiemetics; Methotrexate; Methylprednisolone
  • Indications B-cell lymphoma; Burkitt's lymphoma; Diffuse large B cell lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ITCC-059
  • 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).
    • 13 Dec 2022 Results from the ITCC-059 phase IA and phase II trial presented at the 64th American Society of Hematology Annual Meeting and Exposition

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