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: 17 Aug 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

    • 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.
    • 30 Jun 2017 According to a Pfizer media release, based on the data from this trial, European Commission has approved BESPONSA(inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
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