Management of important adverse events associated with inotuzumab ozogamicin: expert panel review

Bone Marrow Transplant. 2018 Apr;53(4):449-456. doi: 10.1038/s41409-017-0019-y. Epub 2018 Jan 12.

Abstract

Inotuzumab ozogamicin (InO), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic agent calicheamicin, has demonstrated efficacy in the phase 3 INO-VATE study of adults with relapsed or refractory acute lymphoblastic leukemia (ALL). Findings from the study showed clinically important adverse events (AEs) associated with InO, with veno-occlusive disease (VOD) reported as a major non-hematologic AE. Other important or serious AEs include neutropenia, febrile neutropenia, thrombocytopenia, infusion-related reactions, tumor lysis syndrome, and prolonged QT syndrome. This report summarizes the recommendations of an expert panel of hematologists and transplant physicians for evaluation and management of the important AEs associated with InO, with a focus on diagnosis, prevention, monitoring, and management of VOD. The possible interventions considered included prophylaxis medications, patient monitoring and assessment, and InO dose adjustment or discontinuation.

Trial registration: ClinicalTrials.gov NCT01564784.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Clinical Trials as Topic
  • Disease Management
  • Febrile Neutropenia / chemically induced
  • Febrile Neutropenia / diagnosis
  • Febrile Neutropenia / prevention & control
  • Febrile Neutropenia / therapy
  • Hepatic Veno-Occlusive Disease / chemically induced
  • Hepatic Veno-Occlusive Disease / diagnosis
  • Hepatic Veno-Occlusive Disease / prevention & control
  • Hepatic Veno-Occlusive Disease / therapy
  • Humans
  • Inotuzumab Ozogamicin
  • Practice Guidelines as Topic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma / complications
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma / drug therapy*
  • Risk Factors
  • Salvage Therapy / adverse effects*
  • Salvage Therapy / methods
  • Tumor Lysis Syndrome / diagnosis
  • Tumor Lysis Syndrome / etiology
  • Tumor Lysis Syndrome / prevention & control
  • Tumor Lysis Syndrome / therapy
  • Vascular Diseases / chemically induced
  • Vascular Diseases / diagnosis
  • Vascular Diseases / prevention & control
  • Vascular Diseases / therapy

Substances

  • Antibodies, Monoclonal, Humanized
  • Inotuzumab Ozogamicin

Associated data

  • ClinicalTrials.gov/NCT01564784