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

Completed · Phase 4

Conditions studied: ECG, Pharmacokinetics, Safety

In brief

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.

Key facts

Study ID

NCT03727750

Run by

Pfizer

People needed

51

Starts

2019-07-03

Expected to finish

2021-04-27

Last updated by the study team

2022-03-25

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Refractory or relapsed (ie, bone marrow blasts >5%) CD33-positive AML.
• Age >=12 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
• Initial peripheral white blood cells (WBC) counts >=30,000/mL; patients with a higher WBC count should undergo cytoreduction.
• Adequate renal/hepatic functions

You may not qualify if…

• Patients with prior treatment with gemtuzumab ozogamicin (GO).
• Patients with prior history of VOD/SOS.
• Prior HSCT is not allowed, if it was conducted within 2 months prior to study enrollment.
• Patients with known active central nervous system (CNS) leukemia.
• Uncontrolled or active infectious status.
• Uncontrolled cardiac dysrhythmias of NCI CTCAE Grade 2, uncontrolled atrial fibrillation of any grade.
• Sero-positivity to human immunodeficieny virus (HIV).
• Active hepatitis B or hepatitis C infection
• Chemotherapy, radiotherapy, or other anti-cancer therapy (except hydroxyurea as cytoreduction) within 2 weeks prior to enrollment in the study.
• Major surgery within 4 weeks prior to enrollment.
• QTc interval >470 milliseconds (msec) using the Fridericia (QTcF), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP).
• The use of medications known to predispose to Torsades de Pointes within 2 weeks prior to enrollment
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemtuzumab ozogamicin (GO).

Where it is running

• Augusta University Medical Center Clinical Research Pharmacy — Augusta, Georgia, United States
• Georgia Cancer Center at Augusta University — Augusta, Georgia, United States
• Brody School of Medicine at East Carolina University — Greenville, North Carolina, United States
• Vidant Medical Center — Greenville, North Carolina, United States
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Research Transition Facility — Edmonton, Alberta, Canada
• Kaye Edmonton Clinic — Edmonton, Alberta, Canada
• Hamilton Health Sciences, Juravinski Hospital — Hamilton, Ontario, Canada
• Juravinski Cancer Centre — Hamilton, Ontario, Canada
• Semmelweis Egyetem I.sz Belgyogyaszati Klinika, Hematologiai Osztaly — Budapest, Hungary
• Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika — Debrecen, Hungary
• Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat - Hematologiai Osztaly — Győr, Hungary
• Somogy Megyei Kaposi Mor Oktato Korhaz — Kaposvár, Hungary
• Klinika Hematologii i Transplantologii — Gdansk, Poland
• Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
• Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku — Wroclaw, Poland
• Pracownia Tomografii Komputerowej i Pracownia Rezonansu Magnetycznego — Wroclaw, Poland
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
• Hospital Universitario Reina Sofía — Córdoba, Spain
• Hospital General Universitario Gregorio Maranon — Madrid, Spain
• Hospital Universitari i Politecnic La Fe — Valencia, Spain
• The Royal Bournemouth and Christchurch NHS Foundation Trust — Bournemouth, Dorset, United Kingdom
• Belfast Health and Social Care Trust — Belfast, United Kingdom
• Clatterbridge Cancer Center NHS Foundation Trust — Liverpool, United Kingdom

Full record on ClinicalTrials.gov

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