Safety of gemtuzumab ozogamicin as monotherapy or combination therapy in an expanded-access protocol for patients with relapsed or refractory acute myeloid leukemia

Eunice S. Wang, Richard Aplenc, Deborah Chirnomas, Michael Dugan, Salman Fazal, Swaminathan Iyer, Tara L. Lin, Sucha Nand, Kristen J. Pierce, Paul J. Shami, Jennifer J. Vermette, Camille N. Abboud

Research output: Contribution to journalArticlepeer-review

Abstract

Gemtuzumab ozogamicin (GO) remained available to US clinicians through an open-label expanded-access protocol (NCT02312037) until GO was reapproved. Patients were aged ≥3 months with relapsed/refractory (R/R) acute myeloid leukemia (AML), high-risk myelodysplastic syndrome, or acute promyelocytic leukemia (APL), and had exhausted other treatment options. Three hundred and thirty one patients received GO as monotherapy for R/R AML (n = 139), combination therapy for R/R AML (n = 183), or treatment for R/R APL (n = 9). Corresponding treatment discontinuations occurred in 68, 39, and 33% of patients. All-causality grade 5 AEs occurred in 52, 22, and 22% of patients in the monotherapy, combination, and APL groups, respectively. Corresponding grades 3 and 4 treatment-related AEs were reported in 60, 55 and 78% of patients. Hepatotoxicity occurred in five patients: veno-occlusive disease (n = 4) and drug-induced liver injury (n = 1). GO was generally well tolerated in patients with R/R AML or APL. Most frequent treatment-related grade ≥3 AEs were hematologic AEs. Clinicaltrials.gov identifier: NCT02312037.

Original languageEnglish
Pages (from-to)1965-1973
Number of pages9
JournalLeukemia and Lymphoma
Volume61
Issue number8
DOIs
StatePublished - Jul 2 2020

Keywords

  • Acute myeloid leukemia
  • acute promyelocytic leukemia
  • expanded access
  • gemtuzumab ozogamicin
  • myelodysplastic syndrome
  • safety

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