NCT02472145 - An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy | Biotech Hunter

Enrollment

326

Participants

Timeline

Start Date

August 4, 2015

Primary Completion Date

January 25, 2018

Study Completion Date

January 25, 2018

Conditions

Leukemia, Myeloid, Acute

Interventions

DRUG

Decitabine 20 mg/m^2

Decitabine 20 milligram per square meter (mg/\[m\^2\]) from Day 1, 2, 3, 4 and 5 of a 28-day cycle.

DRUG

Talacotuzumab 9 mg/kg

Talacotuzumab 9 milligram per kilogram mg/kg on Day 8 and 22 of a 28-day cycle.

Trial Locations (81)

Unknown

Orange

Aurora

New Orleans

Detroit

Lebanon

New York

Rochester

Charleston

Nashville

Dallas

Houston

Herston

Melbourne

Perth

South Woodville

Woolloongabba

Antwerp

Hasselt

Leuven

Liège

Mons

Turnhout

Wilrijk

Grenoble

Lyon

Marseille

Montpellier

Nantes

Paris

Toulouse

Dresden

Düsseldorf

Essen

Frankfurt am Main

Hamburg

München

Münster

Ulm

Würzburg

Haifa

Jerusalem

Ramat Gan

Tel Aviv

Katowice

Krakow

Lodz

Lublin

Warsaw

Chelyabinsk

Dzerzhinsk

Moscow

Nizhny Novgorod

Ryazan

Samara

Yekaterinburg

Busan

Daegu

Hwasun Gun

Seoul

Badalona, Barcelona

Barcelona

Madrid

Pozuelo de Alarcon, Madrid

Salamanca

Seville

Valencia

Gothenburg

Örebro

Stockholm

Uppsala

Chiayi City

Taichung

Tainan City

Taipei

Ankara

Atakum

Istanbul

Izmir

Bournemouth

Cardiff

Wolverhampton

All Listed Sponsors

lead

Janssen Research & Development, LLC

INDUSTRY