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A SINGLE ARM, OPEN-LABEL, PHASE 4 STUDY EVALUATING QT INTERVAL, PHARMACOKINETICS, AND SAFETY OF GEMTUZUMAB OZOGAMICIN (MYLOTARG (TRADEMARKER)) AS A SINGLE-AGENT REGIMEN IN PATIENTS WITH RELAPSED OR REFRACTORY CD33-POSITIVE ACUTE MYELOID LEUKEMIA

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Trial Profile

A SINGLE ARM, OPEN-LABEL, PHASE 4 STUDY EVALUATING QT INTERVAL, PHARMACOKINETICS, AND SAFETY OF GEMTUZUMAB OZOGAMICIN (MYLOTARG (TRADEMARKER)) AS A SINGLE-AGENT REGIMEN IN PATIENTS WITH RELAPSED OR REFRACTORY CD33-POSITIVE ACUTE MYELOID LEUKEMIA

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 03 May 2023

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At a glance

  • Drugs Gemtuzumab ozogamicin (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions
  • Sponsors Pfizer

    • Most Recent Events

    • 24 Mar 2023 Results (n=50) assessing to characterize the PK of single-agent GO following the fractionated dosing regimen in patients with relapsed/refractory acute myeloid leukemia from NCT03727750 study, presented at the 124th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 24 Mar 2023 Results characterizing the relationship between QTc and concentrations of GO using data from a post marketing requirement study (NCT03727750), presented at the 124th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 17 Jun 2022 Results assessing the effect of fractionated Gemtuzumab Ozogamicin as monotherapy on corrected QT interval, safety, pharmacokinetics and immunogenicity of Gemtuzumab Ozogamicin in patients with relapsed/refractory acute myeloid leukemia, presented at the 27th Congress of the European Haematology Association.

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