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

PHASE4CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

July 3, 2019

Primary Completion Date

April 27, 2021

Study Completion Date

April 27, 2021

Conditions
ECGPharmacokineticsSafety
Interventions
DRUG

Gemtuzumab Ozogamicin

Three doses of GO 3 mg/m2 (up to one vial) as a 2 hour intravenous infusion on Cycle 1 Days 1, 4, and 7. A second cycle of GO 3mg/m² (up to one vial) on Cycle 2 Days 1, 4, and 7 will be allowed at the investigator's discretion for patients who meet the criteria

Trial Locations (24)

1083

Semmelweis Egyetem I.sz Belgyogyaszati Klinika, Hematologiai Osztaly, Budapest

4032

Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Debrecen

7400

Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár

9024

Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat - Hematologiai Osztaly, Győr

14004

Hospital Universitario Reina Sofía, Córdoba

27834

Brody School of Medicine at East Carolina University, Greenville

Vidant Medical Center, Greenville

28007

Hospital General Universitario Gregorio Maranon, Madrid

30912

Augusta University Medical Center Clinical Research Pharmacy, Augusta

Georgia Cancer Center at Augusta University, Augusta

46026

Hospital Universitari i Politecnic La Fe, Valencia

T6G 2B7

University of Alberta Hospital, Edmonton

T6G 2V2

Research Transition Facility, Edmonton

T6G1Z1

Kaye Edmonton Clinic, Edmonton

L8V 1C3

Hamilton Health Sciences, Juravinski Hospital, Hamilton

L8V 5C2

Juravinski Cancer Centre, Hamilton

80-214

Klinika Hematologii i Transplantologii, Gdansk

Uniwersyteckie Centrum Kliniczne, Gdansk

50-367

Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku, Wroclaw

50-369

Pracownia Tomografii Komputerowej i Pracownia Rezonansu Magnetycznego, Wroclaw

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

BH7 7DW

The Royal Bournemouth and Christchurch NHS Foundation Trust, Bournemouth

BT9 7AB

Belfast Health and Social Care Trust, Belfast

L7 8XP

Clatterbridge Cancer Center NHS Foundation Trust, Liverpool

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT03727750 - Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML | Biotech Hunter | Biotech Hunter