An Open-label, Randomized Phase 3 Study Of Inotuzumab Ozogamicin Compared To A Defined Investigator's Choice In Adult Patients With Relapsed Or Refractory Cd22-positive Acute Lymphoblastic Leukemia (All)

Trial Profile

An Open-label, Randomized Phase 3 Study Of Inotuzumab Ozogamicin Compared To A Defined Investigator's Choice In Adult Patients With Relapsed Or Refractory Cd22-positive Acute Lymphoblastic Leukemia (All)

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Dec 2017

At a glance

  • Drugs Inotuzumab ozogamicin (Primary) ; Cytarabine; Fludarabine; Granulocyte colony stimulating factor stimulants; Mitoxantrone
  • Indications Acute lymphoblastic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms INO-VATE ALL; Study 1022
  • Sponsors Pfizer
  • Most Recent Events

    • 12 Oct 2017 Results assessing quality-adjusted life years for inotuzumab ozogamicin versus investigators choice for relapsed/refractory B-cell acute lymphoblastic leukaemia, were presented at the 20th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 17 Aug 2017 Results published in a Pfizer Media Release.
    • 17 Aug 2017 According to a Pfizer media release, based on the data from this trial, the U.S. Food and Drug Administration (FDA) has approved BESPONSA (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). BESPONSA was reviewed and approved under the FDAs Breakthrough Therapy designation and Priority Review programs.
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