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

• Status: Completed
• Trial end date: 2021-04-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Gemtuzumab

Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).