Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML

Phase 4 Completed 51 enrolled Pfizer

NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory CD33-positive AML.

Timeline

Start: 2019-07-03
Primary completion: 2021-04-27
Completion: 2021-04-27

Publications

Montesinos P, Kota V, Brandwein J, Bousset P, Benner RJ, Vandendries E, Chen Y, McMullin MF. A phase IV study evaluating QT interval, pharmacokinetics, and safety following fractionated dosing of gemtuzumab ozogamicin in patients with relapsed/refractory CD33-positive acute myeloid leukemia. Cancer Chemother Pharmacol. 2023 May;91(5):441-446. doi: 10.1007/s00280-023-04516-9. Epub 2023 Mar 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemtuzumab Ozogamicin	Monoclonal antibody	3 mg/m2	—

Indications

No indication recorded.