Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

February 14, 2017

Primary Completion Date

January 23, 2019

Study Completion Date

October 5, 2021

Conditions
Myelodysplastic Syndromes
Interventions
DRUG

Talacotuzumab

Talacotuzumab 9 mg/kg will be administered as an IV infusion.

DRUG

Daratumumab

Daratumumab 16 mg/kg will be administered as an IV infusion.

Trial Locations (21)

2060

ZNA Stuivenberg, Antwerp

2300

AZ Turnhout, Turnhout

3000

UZ Leuven, Leuven

8500

Az Groeninge, Kortrijk

19104

University of Pennsylvania Abramson Cancer Center, Philadelphia

20089

Istituto Clinico Humanitas, Rozzano

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora, Milan

28006

Hosp. Univ. de La Princesa, Madrid

37007

Hosp Clinico Univ de Salamanca, Salamanca

40138

Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna, Bologna

46026

Hosp. Univ. I Politecni La Fe, Valencia

50134

Azienda Ospedaliero Universitaria Careggi, Florence

63110

Washington University School Of Medicine, St Louis

77030

University of Texas, MD Anderson Cancer Center, Houston

123182

Saint Petersburg City Hospital #15, Saint Petersburg

129301

City Clinical Hospital # 40, Moscow

603126

Nizhniy Novgorod Region Clinical Hospital, Nizhny Novgorod

9713 GZ

UMCG, Groningen

3075 EA

Erasmus MC, Rotterdam

2545 CH

Haga ziekenhuis, The Hague

08035

Hosp Univ Vall D Hebron, Barcelona

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03011034 - Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment | Biotech Hunter | Biotech Hunter